QA Compliance Officer

  • Location: Geel
  • Type: Contracting
  • Job #18349

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

QA Compliance Officer

Within the QA operations department we are looking for a QA specialist for production plant 1. In this position you are responsible for quality support for the introduction and project integration of multiproduct launch unit, a standardized mAbs process platform, in the existing APU plant 1 organization
Location: Geel

Scope of work:

  • Drafting and reviewing Quality documentation in the context of the project (Project notes, Quality plans, …)
  • Follow up and review of general project documentation (risk assessments, validation plans, procedures, batch records, …)
  • Sharing quality support and expertise related to clinical manufacturing vs commercial manufacturing
  • Prepare and review project documentation (e.g. procedures, risk assessments) with a view to deviation prevention (DPP) and human error prevention (HEP)
  • Be in compliance with SOPs, global standards, regulations and product registration (filing) related to clinical and commercial manufacturing
  • Provide quality support for process validation activities
  • Execution of GEMBA (e.g. follow-up of physical project works, shakedowns, Deviation prevention, …)

Who are you?

  • Master in a scientific direction or equivalent through experience
  • Knowledge and interpretation of cGMP in a regulated environment
  • Knowledge and interpretation of clinical manufacturing and regulations is an advantage
  • Knowledge and experience with Quality Processes and Quality Assurance
  • Superb accuracy and attention to detail
  • Independence and a strong sense of responsibility
  • An enthusiastic team player and strong in communication
  • Good writing skills
  • Good knowledge of the English language

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Clinical Research Specialist

  • Location: Diegem
  • Type: Contracting
  • Job #18346

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Clinical Research Specialist

The Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Location: Diegem

Scope of work:

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position:

• Serves as a Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, under supervision;

• Participates in the feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;

• May serve as the primary contact for clinical trial sites (e.g. site management);

• Assists in the development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);

• Supports applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;

• Coordinates and executes ordering, tracking, and accountability of investigational devices and trial materials;

• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;

• Interfaces and collaborates with Clinical Research Associates (CRAs);

• Assists in overseeing and supports the development and execution of Investigator agreements and trial payments;

• Assists in clinical data review to prepare data for statistical analyses and publications;

• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;

• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;

• Assists in tracking assigned project budgets;

• May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);

• May perform other duties assigned as needed;

• Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;

• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;

• Should develop a strong understanding of the pipeline, product portfolio and business needs;

• Generally manages work with supervision. Independent decision-making for simple situations but requires guidance for complex situations.

Who are you?

Education

  • Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

 

Experience

• BS with at least 2 years, MS and PhD with at least 1 year of relevant experience preferred.

• Previous experience in clinical research or equivalent is desired.

• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).

• Clinical/medical background is a plus.

• Medical device experience is a plus.

 

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES & AFFILIATIONS

Functional and Technical Competencies:

• Good understanding of clinical research science and processes, clinical trends, and global clinical trial regulations;

• Proven track record in supporting clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;

• Presentation and technical writing skills;

• Written and oral English communication skills.

 

Leadership Competencies:

Strong leadership required in alignment with intenal Leadership Imperatives:

• Connect – Develop collaborative relationships with key internal and external stakeholders.

• Shape – Actively participate in departmental process improvement activities.

• Lead – Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.

• Deliver – Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.

 

LOCATION & TRAVEL REQUIREMENTS

• Primary location for this position is Diegem. At management discretion, the position may be performed remotely.

• Ability to travel approximately 20% depending on the phase of the program.

 

EXTERNAL INTERACTIONS

• Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical research as well as those being evaluated.

• May have regular interaction with third party vendors supporting clinical studies as applicable per clinical trial.

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Clinical Research Leader

  • Location: Diegem
  • Type: Contracting
  • Job #18347

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Clinical Research Leader

The Clinical Research Leader will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Location: Diegem

Scope of work:

Under minimal supervision and in accordance with all applicable federal, state and local laws/regulations and corporate procedures and guidelines, this position:

• Serves as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Operating Company;

• Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;

• May serve as the primary contact for clinical trial sites (e.g. site management);

• Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports);

• Ensures applicable trial registration (e.g. on www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;

• Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials;

• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel;

• Interfaces, collaborates and oversees Clinical Research Associates (CRAs);

• Oversees and supports the development and execution of Investigator agreements and trial payments;

• Is responsible for clinical data review to prepare data for statistical analyses and publications;

• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;

• May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS), with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), contributing to cross-functional alignment;

• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;

• Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated;

• Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);

• Supports planning, track and manage assigned project budgets to ensure adherence to business plans;

• Supports clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy;

• May serve as the clinical representative on a New Product Development team;

• May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant;

• May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims

and messaging;

• Manages and/or mentors resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency;

• May act as Clinical Safety Coordinator (See ANNEX I – Clinical Safety Coordinator Duties and Responsibilities);

• May perform other duties assigned as needed;

• Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;

• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;

• Should develop a strong understanding of the pipeline, product portfolio and business needs;

• Generally manages work with limited supervision, dependent on project complexity.

Independent decision-making for simple and more advanced situations but requires minimal guidance for complex situations.

 

Who are you?

Education

  • Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

 

Experience

• BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.

• Previous experience in clinical research or equivalent is required.

• Experience working well with cross-functional teams is required.

• Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).

• Clinical/medical background is a plus.

• Medical device experience is highly preferred.

 

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES & AFFILIATIONS

Functional and Technical Competencies:

• Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;

• Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects;

• Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;

• Strong presentation and technical writing skills;

• Strong written and oral English communication skills;

• Demonstrate competencies in the following area are required:

• Behave and lead in a professional and ethical manner

• Advanced project management skills with ability to handle multiple projects

 

Leadership Competencies:

Strong leadership required in alignment with intenal Leadership Imperatives:

• Connect – Develop collaborative relationships with key internal and external stakeholders.

• Shape – Actively participate in departmental process improvement activities.

• Lead – Take ownership in critical scientific thinking and development of self and engage in transparent and constructive conversations.

• Deliver – Strive to ensure all deliverables on allocated studies are met on time, within budget and in compliance to SOPs and regulations.

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Commissioning Engineer

  • Location: Geel
  • Type: Contracting
  • Job #18348

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Commissioning Engineer

The Commissioning Engineer will be responsible for the commissioning of designated systems (both utility and process). The role will involve guiding a small team, as well as part of the larger ICV organization and engaging with various groups including design, construction, manufacturing, quality & engineering for the project.
Location: Geel

Scope of work:

The role of the commissioning engineer will be one of direct responsibility, on behalf of our client, for the successful commissioning of defined systems. (incl. loop checks and passivation, where applicable).

Reporting to the Commissioning Lead or manager, the role of the commissioning engineer will be as follows:

  • Write, review and approve commissioning & qualification protocols and reports, as well as execute protocols.
  • Work together with a small team of start-up personnel (incl. engineers, mechanical craft persons, E&I technicians, vendors etc.) and sometimes alone, to successfully execute start-up activities safely and to a high quality, based on the overall ICV schedule, for assigned systems.
  • Familiarize oneself with all elements of the process & utility design for assigned systems. This to be achieved through documentation & drawing review with the engineering company (JE), Construction Management Team & internal team members.
  • Engage with the Construction Management Team & internal Construction team to review and approve the field installation (as per design) at Mechanical Completion. (P&ID Walk Downs)
  • Perform commissioning in a GMP biotech manufacturing facility
  • Provide technical assistance to less experienced technicians/engineers.
  • Review/approve commissioning documentation (e.g. vendor test documentation) for assigned systems
  • Resolve protocol discrepancies and deviations.
  • Generate, review and approve deviations
  • Report & follow up on deviations, solving technical problems
  • Participate in risk assessments
  • Perform change control assessment
  • Follow-up of changes via the applicable project change control procedure
  • Follow up on changes in own domain and communicate them to the relevant functions
  • Overseeing activities performed by third parties
  • Engage with technical support functions (e.g. process, automation etc.) to resolve issues quickly as they arise through commissioning execution.
  • Report on progress – frequency as per requested by Commissioning Lead.
  • Train operations personnel in system operations.

Who are you?

Must

  • A minimum of 5 years’ experience in a process or start-up role in the pharmaceutical industry.
  • Strong interpersonal, organizational, and technical skills.
  • Capability to work both independently and in a team environment.
  • Strong analytical and communication skills are required.
  • Strong Quality & Safety focus
  • Proficiency in Microsoft Office incl. Word, Excel, PowerPoint, Project and Visio.
  • Capable of leading teams to deliver results, including project management and KPI reporting
  • Excellent written and verbal presentation skills to support interactions with senior leadership and inspectors.
  • Knowledge of cGMP in a regulated environment
  • Knowledge of English is a must, knowledge of Dutch is a plus.

 

Nice to have

  • Familiarity with applicable regulatory compliance requirements for biotech operations incl. area classifications etc.
  • Ability to read/interpret engineering drawings and design documents.
  • Management of medium to large size projects.
  • Excellent technical writing and verbal communication skills.
  • Knowledge of process & clean utility design
  • Knowledge of Validation Lifecycle Approach.
  • Strong mentoring and development experience.
  • Must be able to establish strong working relationships with stakeholders (Quality, Manufacturing and MSAT) to ensure high quality deliverables meeting CGMP and site quality requirements.
  • Understanding of Validation using risk-based approach
  • Demonstrated success working across organizations in highly cross-functional team environment.
  • Degree of Masters Qualification in Science or Engineering is a plus.
  • Experience with the Kneat application is a plus
  • Knowledge of (use) DeltaV / BMS is a plus
  • Valid VCA or equivalent is a must, valid VOL VCA or equivalent is a plus

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Clinical Research Manager

  • Location: Diegem
  • Type: Contracting
  • Job #18345

JJJP00011538

 

Description:

 

Clinical Research Manager (Clinical R&D)

JOB SUMMARY
This Clinical Research Manager will be responsible for clinical trial management within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.

DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
• Has oversight of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
• Manages and oversees ordering, tracking, and accountability of investigational products and trial materials;
• Ensures applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
• Is responsible for team’s interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel;
• Is responsible for clinical data review to prepare data for statistical analyses and publications;
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
• Contribute to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), ensuring cross-functional alignment;
• Ensures input and strong alignment from key regional Clinical R&D leads and other strategically important countries/ regions in the development of the EGS/ EDS;
• Leads in study design to develop appropriate clinical trials to meet the clinical evidence needs;
• May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
• Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.;
• Is responsible for delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
• Plans, tracks and manages assigned project budgets to ensure adherence to business plans;
• Contributes in clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc. including during sponsor regulatory inspections;
• Serves as the clinical representative on a New Product Development team;
• Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;
• Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
• Is responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition;
• Manages and mentors resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency;
• Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;
• May perform other duties assigned as needed;
• Is responsible for communicating business related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
• Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
• Should develop a strong understanding of the pipeline, product portfolio and business needs;
• Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed.

EXPERIENCE AND EDUCATION
Education
• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.

Experience
• A minimum of 8 years related scientific/ technical experience, including leadership/management role within Clinical Research.
• Significant previous experience in clinical project leadership across multiple studies/ programs is required.
• Experience working well with cross-functional teams is required.
• Experience with budget planning, tracking and control is required.
• Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
• Clinical/medical background is a plus.
• A minimum of 1-2 year people management related experience is a plus.
• Medical device experience is highly preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES & AFFILIATIONS
Functional and Technical Competencies:
• Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
• Ability to provide scientifically strategic and scientific clinical research input across New Product Development and Life-Cycle Management projects, including complex and/ or transformational projects;Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
• Strong presentation and technical writing skills;
• Strong written and oral English communication skills;
• Comprehensive understanding of clinical trial regulations across multiple regions;
• Demonstrates competencies in the following area are required:
o Ability to lead teams to deliver critical milestones, including complex projects
o Strong project management skills with ability to handle multiple projects
o Strong people management skills
o Change agent in team development and progression

Leadership Competencies:
Strong leadership required in alignment with J&J Leadership Imperatives:
• Connect – Develop strong collaborative relationships with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/ EDS. Create strong and productive partnership with resource providers and vendors.
• Shape – Make recommendations for and actively participate and lead in departmental process improvement activities. Through efficient use of resources, shape the way clinical trial management is conducted and resources are utilized.
• Lead – Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues.
• Deliver – Ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned.

RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
• Reports to Clinical Research Associate Director or Clinical Research Director
• Functions that this position is responsible for (direct/ indirect management):
o Clinical Study Administrator
o Clinical Research Specialist
o Senior Clinical Research Specialist
o Clinical Research Leader
• Expected to build collaborative relationships with key internal partners and stakeholders. Ref. duties and responsibilities section.

LOCATION & TRAVEL REQUIREMENTS
• Primary location for this position is Diegem.
• Ability to travel approximately 20-25% depending on the phase of the program.

EXTERNAL INTERACTIONS
• Interaction with physicians and research staff at centers selected for involvement in clinical research

Education Required  

Doctorate (PHD) or Equivalent

Job Function  

R&D

Job Subfunction  

Clinical Research MD

Site Access  

Off-Site with Site Access

Work Experience  

Generally Requires 8-10 Years Work Experience

Permanent Salary Equivalent Rate  

0,00

Project Engineer Piping

  • Location: AALTER
  • Type: Contracting
  • Job #18341

Projectingenieur

Vast contract – regio Gent

#Piping #industrial #Utilities #Safety

Ben je in het bezit van een bachelor- of masterdiploma in de techniek? Heb jij werkervaring met leidingontwerp en projectmanagement? Heb jij leidinggevende kwaliteiten en werk je met oog voor kwaliteit en veiligheid? Lees dan verder!

Onze partner is op zoek naar een hands-on Project Engineer om een groot piping project in goede banen te leiden. Dit toonaangevende bedrijf in Oost-Vlaanderen is wereldwijd actief in de voedingssector en staat bekend om hun duurzame samenwerking met de Belgische landbouwbedrijven.

jouw verantwoordelijkheden?

Als Project Engineer werk je in een cleane industriële omgeving en ben je verantwoordelijk voor het Piping Projectteam. Je taken bestaan ​​uit een aantal verschillende werkzaamheden:

  • Opvolgen van leveranciers, engineering en bouwaannemers.
  • Fungeren als liaison met collega's van de site, afdelingscollega's en andere belanghebbenden.
  • Opvolgen en verantwoordelijk zijn voor discipline kwaliteit, planning, aankoop en budget.
  • Opvolgen en optimaliseren van leidingontwerp en 3D-modelontwikkeling specifiek voor Clean Utilities / CIP
  • Voorbereiden van technische evaluaties en safety audits en procedures

Wie ben jij?

Om bovenstaande taken en verantwoordelijkheden succesvol uit te voeren, beschik je over een Master of Bachelor diploma aangevuld met een goede kennis van piping design en ervaring in project management. Daarnaast heb je een hands-on mentaliteit en hecht je erg veel belang aan veiligheid op de werkvloer! Tot slot ben je ook een echte teamspeler met sterke communicatieve vaardigheden. Goede kennis van Nederlands is een vereiste.

Het zelf in staat zijn en bereid zijn om LOTOTO voor te bereiden, P&ID's / HAZOP / HACCP te herzien en te verbeteren en Validatie en CSU uit te voeren wordt aanzien als een sterke PLUS!

Wat kunt u verwachten?

Als Project Engineer werk je in een dynamische en open omgeving met gezellige collega's. Bovendien ontvang je een aantrekkelijk salaris aangevuld met een uitgebreid pakket aan extralegale voordelen en een direct vast contract. Ten slotte krijg je de mogelijkheid voor persoonlijke en professionele ontwikkeling door interne training en opleiding.

Interesse in deze of andere opportuniteiten? Aarzel dan niet om je CV te sturen naar sara.vandenbossche(at)jeffersonwells.be of bel op het nummer (+32) 0472.79.10.42

Piping Engineer

  • Location: AALTER
  • Type: Contracting
  • Job #18313

Piping Engineer

Vast contract – regio Gent

#Piping #industrial #Utilities #Safety

Heb jij werkervaring met leidingontwerp en hou je ervan om dagelijks op de werkvloer te staan in het kader van lassupervisies en systeemvalidatie? Heb een hands-on mentaliteit en werk je met oog voor kwaliteit en veiligheid? Lees dan verder!

Onze partner is op zoek naar een hands-on Piping Engineer om deel uit te maken van een groot piping project. Dit toonaangevende bedrijf in Oost-Vlaanderen is wereldwijd actief in de voedingssector en staat bekend om hun duurzame samenwerking met de Belgische landbouwbedrijven.

jouw verantwoordelijkheden?

Als Piping Engineer zal je tewerkgesteld zijn in een cleane industriële omgeving. Je taken bestaan ​​uit een aantal verschillende werkzaamheden:

  • Safety supervisie zoals voorbereiden en uitvoeren van LOTOTO, LMRA, …
  • Opvolgen en optimaliseren van P&ID’s en 3D-modelontwikkeling specifiek Clean Utilities / CIP
  • Voorbereiden van technische evaluaties, lasinspecties en validatie van de systemen

Wie ben jij?

Om bovenstaande taken en verantwoordelijkheden succesvol uit te voeren, beschik je over een technisch diploma aangevuld met een goede kennis van piping design en lasprocedures. Daarnaast heb je een hands-on mentaliteit en hecht je erg veel belang aan veiligheid op de werkvloer! Tot slot ben je ook een echte teamspeler met sterke communicatieve vaardigheden. Goede kennis van Nederlands is een vereiste.

Reeds ervaring in het werken in de Pharma of Voedingsindustrie (bekend met HAZOP / HACCP) wordt aanzien als een plus!

Wat kunt u verwachten?

Als Piping Engineer werk je in een dynamische en open omgeving met gezellige collega's. Bovendien ontvang je een aantrekkelijk salaris aangevuld met een uitgebreid pakket aan extralegale voordelen en een direct vast contract. Ten slotte krijg je de mogelijkheid voor persoonlijke en professionele ontwikkeling door interne training en opleiding.

Interesse in deze of andere opportuniteiten? Aarzel dan niet om je CV te sturen naar sara.vandenbossche(at)jeffersonwells.be of bel op het nummer (+32) 0472.79.10.42

Lead Technician Formulatie

  • Location: PUURS
  • Type: Contracting
  • Job #18344

Word jij onze nieuwe ambassador? 

Jefferson Wells Life Sciences is gespecialiseerd in de ondersteuning van farma & biotech bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in experts zoals jij om ons team te versterken.

Laten we samen kijken naar jouw eerste challenge bij ons!

Lead Technician Formulatie

Als Lead Technician ben je het eerste aanspreekpunt omtrent alle technische breakdowns binnen jouw afdeling.

In deze functie hoef je niet in 3 ploegen te werken. Normaliter enkel dag-dienst, maar igv langere afwezigheid van een ploegtechnieker kan het zijn dat je even in ploegen moet meedraaien. (voorbeeld: tijdens groot verlof)

We geloven sterk in team werk! Daarom zijn onderstaande taken wel typisch voor de Lead Technician, maar staat het uiteindelijke resultaat van het team boven alles
Locatie: Puurs

 

Belangrijkste taken in jouw rol zijn:

  • Verantwoordelijk voor het oplossen van breakdowns in de eigen afdeling
  • Verantwoordelijk voor het uitvoeren van preventieve en correctieve onderhoudstaken in de eigen afdeling.
  • Je ondersteunt systemen om kennis te borgen (productie betrekken bij het oplossen van problemen, werkorders correct opstellen, expertsystemen aanvullen, technische trainingen procedures uitwerken…)
  • Je werkt mee in projecten onder het technische luik

 

Your Profile:

Must

  • Opleidingsniveau: professionele bachelor/voormalig graduaat Elektromechanica met bij voorkeur 3 jaar ervaring in een vergelijkbare functie of gelijkwaardig door ervaring
  • Heeft de nodige communicatieve en analytische vaardigheden en kan zowel zelfstandig als in teamverband vlot functioneren.
  • Kan elektrische en pneumatische schema’s lezen en interpreteren
  • Is vertrouwd met schakelmateriaal, elektrische componenten, frequentieomvormers, meetinstrumenten en transmitters.
  • Is in staat een P&ID te interpreteren.
  • Heeft de nodige kennis, inzicht en methodiek inzake veiligheid.
  • Heeft een goede kennis van elektriciteit, geautomatiseerde controlesystemen en PC-toepassingen (MS-office).
  • Werkt methodisch en gedocumenteerd (gebruik EAMS, expertsysteem…)
  • Staat open voor vernieuwingen en veranderingen en is bereid zich continu bij te scholen.
  • Normaal regime: Dag dienst, maar beschikbaar om vroege/late ploeg over te nemen van shifttechnieker bij langdurige afwezigheid.

 

Nice to have

  • Ervaring in een GMP omgeving (specifiek preparatie, filling, inspectie en/of verpakking)

 

Wat kan Jefferson Wells voor jou betekenen?

Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen.

Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer nu met jouw cv!

 

Analist Farmacopee

  • Location: PUURS
  • Type: Contracting
  • Job #18343

Word jij onze nieuwe ambassador? 

Jefferson Wells Life Sciences is gespecialiseerd in de ondersteuning van farma & biotech bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in experts zoals jij om ons team te versterken.

Laten we samen kijken naar jouw eerste challenge bij ons!

Analist Farmacopee
Locatie: Puurs

Your Profile:

  • Ervaring Farmacopee
  • Minstens één jaar ervaring
  • Jij bent iemand die vlot Nederlands en Engels kan
  • Jij bent iemand die GMP getraind is
  • Jij hebt een bachelor diploma op zak of gelijkwaardig qua ervaring
  • Jij bent iemand die stevig in zijn schoenen kan staan

Wat kan Jefferson Wells voor jou betekenen?

Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen.

Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer nu met jouw cv!

Quality Specialist Operations

  • Location: PUURS
  • Type: Contracting
  • Job #18323

Word jij onze nieuwe ambassador? 

Jefferson Wells Life Sciences is gespecialiseerd in de ondersteuning van farma & biotech bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in experts zoals jij om ons team te versterken.

Laten we samen kijken naar jouw eerste challenge bij ons!

Quality Specialist Operations

In deze rol zorg je ervoor dat alle producten voldoen aan interne en externe kwaliteitsstandaarden en geproduceerd worden volgens de huidige productiestandaarden van onze klant en wettelijke vereisten.

Deze functie rapporteert aan de Quality Team Leader Operations.

Je bent verantwoordelijk voor de behandeling van kwaliteitsafwijkingen en de dagelijkse support van een bepaalde productie- of QC-afdeling.
Locatie: Puurs

Belangrijkste taken in jouw rol zijn:

  • De evaluatie van kwaliteitsincidenten en root cause onderzoeken, correctieve en preventieve acties, en evaluatie van de effectiviteit van de preventieve acties om weerkerende deviaties te voorkomen.
  • Het tijdig toepassen van de escalatieprocedure naar de Quality Team Leader Operations en het hoger management.
  • Nauwe samenwerking met de Productie of QC afdeling (o.a. aanwezigheid op dagelijks overleg) en met ondersteunende afdelingen (Product Support, Production Support…) om de vereiste kwaliteit en normen te bereiken, evenals proactief te verbeteren binnen de Productie of QC omgeving.
  • Eerste aanspreekpunt voor kwaliteit in het algemeen binnen jouw area. Algemeen vertegenwoordiger van QA in het Operations Team.
  • Nauwe samenwerking met QP Product Specialists en Supply Chain Management om te verzekeren dat deviaties tijdig afgerond kunnen worden zodat batchen tijdig vrijgegeven kunnen worden naar de markt.
  • Support van audits (voorbereiding en toelichting deviaties).

Your Profile:

Must

  • Je hebt een universitaire wetenschappelijke opleiding gevolgd, bij voorkeur Farmacie. Gecertifieerd zijn als Qualified Person is een meerwaarde.
  • Je hebt een goede kennis en begrip van de cGMP’s.
  • Je hebt goede faciliterende capaciteiten en je bent een echte team player.
  • Je hanteert een pragmatische aanpak en je bent gedreven tot het vinden van oplossingen en boeken van resultaten.
  • Je hebt sterke “technical writing en documentation skills” (Nederlands en Engels).
  • Je bent klantgericht en weet je stakeholders te beïnvloeden.
  • Communicatief ben je sterk en weet je collega's op verschillende niveaus te motiveren en te
  • inspireren (onderhandelen, assertief, overtuigend, diplomatiek…), zowel in het Nederlands als in het Engels (verbaal en schriftelijk).
  • Je kan je organiseren in een omgeving met wisselende prioriteiten (goede “time management” skills en bepalen van prioriteiten).

Nice to have

  • Werkervaring in een aseptische productie omgeving en/of ervaring met de behandeling van kwaliteitsincidenten van geneesmiddelen/vaccins is een meerwaarde.

Wat kan Jefferson Wells voor jou betekenen?

Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen.

Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer nu met jouw cv!