Vast contract of freelance – regio Gent #production #tools #installations
Ben jij een veelzijdige technische professional met een brede skillset? Heb je ervaring met projectmanagement en weet je elektromechanische componenten en installaties succesvol te begeleiden? Heb je een passie voor het optimaliseren van productieprocessen? Dan is deze functie echt iets voor jou!
Voor een klant regio Gent zijn we op zoek naar eenManufacturing Tools & Equipment Engineer (m/v/x). Voel jij jezelf klaar voor deze uitdaging? Wil je samen met Jefferson Wells deze uitdaging aangaan? Lees dan zeker verder!
Jouw verantwoordelijkheden?
Als Manufacturing Tools & Equipment Engineer sta je in voor de uitwerking en uitrol van verschillende nieuwe tools en installaties. Jouw takenpakket:
Je stelt de technische specificaties op vanuit de afdelingen productie, engineering, logistiek, infrastructuur, onderhoud en veiligheid
Je berekent technische capabiliteit en bespreekt deze duurzame oplossingen met de leverancier
Je stelt een tijds- en financieel plan op en zorgt voor een adequate opvolging
Je verzorgt een vlotte transfer van je projecten naar operations
Je streeft steeds naar optimalisatie en continue verbeteringen van je productieafdeling
Wie ben je?
Om de rol van Manufacturing Tools & Equipment Engineer goed in te vullen beschik bij voorkeur over Bachelor of Masterdiploma in ontwerp en productietechnologie en/of elektromechanica met idealiter al een eerste ervaring in projectwerk of werkvoorbereiding. Je beschikt over coördinerende en communicatieve vaardigheden en bezit reeds bewezen expertise in het omgaan met leveranciers. Als persoon ben je gedreven en steeds op zoek naar verbeteringen. Je kan zowel individueel te werk, maar legt ook een grote focus op teamwork. Je communiceert vlot in Nederlands en in hetEngels.
Kennis van Automatisatie wordt voor enige projecten aanzien als een PLUS!
Wat kan je verwachten?
Als Manufacturing Tools & Equipment Engineer krijg je een aantrekkelijke verloning aangevuld met een uitgebreid pakket aan extralegale voordelen en een onmiddellijk vast contract van onbepaalde duur. Ten slotte geniet je de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen door interne trainingen en opleidingen.
Functie ook beschikbaar voor freelancers!
Voldoet deze vacature aan jouw verwachtingen? Aarzel dan niet om te solliciteren via de website of contacteer Sara Van den Bossche op het nummer: (+32) 04 72 79 10 42 of stuur een mailtje naar: Sara.vandenbossche(at)jeffersonwells.be
Your responsibilities: As a part of the Internal Bio & GT Manufacturing Systems Quality Team, you will:
Work closely with Clinical Manufacturing Teams to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
More specifically, provide quality support for qualification and validation activities related to Clinical Manufacturing activities like facilities cleaning processes, viable and non-viable environmental monitoring, equipment and system qualification/validation
Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review…)
Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect the company development activities and products.
Support Change Control and perform the QA evaluation
Ensure KPI (including extracts) are adequately maintained and Shared.
Ensure Issued Copy document are following the issued copy and reconciliation process
Your profile:
Master’s degree in Sciences
Fluency in French and English
A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems are an asset.
Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business
Understands practical applications of GMP, compliance principles and theories including risk management
Ability to work autonomously for the assigned activities with limited supervision
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Vast Contract – Regio Antwerpen #E&I #energiesystemen #continuous #improvement
Beschik je over een master in een technische richting? Heb je werkervaring met Energie en E&I-systemen en de optimalisatie hiervan? Heb je kennis van E-plan of Autocad en werk je doelgericht? Lees dan vooral verder!
Onze partner is op zoek naar een Energy Engineer om hun onderhoudsteam te versterken. Dit toonaangevend distributiebedrijf gelegen in Antwerpen is wereldwijd actief binnen de maritieme- en logistieke sector en staat bekend omwille van opslag van vloeibare bulkgoederen.
Jouw verantwoordelijkheden?
Als Energy Engineer kom je terecht in een grootschalige en dynamische omgeving en krijg je de verantwoordelijkheid over het overkoepelende beheer van E&I- en energiesystemen. Je zorgt voor optimalisatie en ontwikkelt een lange termijnstrategie. Jouw takenpakket bestaat uit een aantal gevarieerde activiteiten:
Je waarborgt de prestaties, veiligheid en betrouwbaarheid van E&I-systemen.
Je analyseert en optimaliseert energievoorziening en -verbruik en implementeert efficiëntere processen.
Je bent het aanspreekpunt voor de E&I installaties en optimaliseert diverse preventieve inspectie- en onderhoudsprogramma’s.
Je leidt RCA analyses en stelt verbeteringen voor waar nodig.
Je volgt contractors en stuurt bij waar nodig.
Je biedt ondersteuning bij de indienststelling van nieuwe installaties en geeft de nodige opleidingen.
Je neemt deel aan klantenaudits.
Je adviseert en ondersteunt de SHEQ-afdeling bij veiligheidsstudies op technisch gebied
Je rapporteert aan de chief maintenance.
Wie ben je?
Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als Energy Engineer over een Master in een technische richting (idealiter elektrotechniek)aangevuld met een eerste ervaring met continue verbetering processen. Kennis vanE-plan of Autocad is een pluspunt. Je bent communicatief vaardig in het Nederlands en Engels. Daarnaast heb je een plichtsbewuste ingesteldheid en een sterke veiligheidszin. Tot slot ben je ook een analytisch persoon met sterke communicatievaardigheden.
Wat kan je verwachten?
Als Energy Engineer kom je terecht in een dynamische en open werkomgeving met aangename collega’s. Bovendien krijg je een mooie verloning aangevuld met een uitgebreid pakket aan extralegale voordelen en een onmiddellijk vast contract van onbepaalde duur. Ten slotte geniet je de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen door interne trainingen en opleidingen.
Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Jens Blanchet op het nummer +32 (0)479 43 32 62 of via jens.blanchet(@)jeffersonwells.be.
Your responsibilities: Our client is looking for a Procurement Specialist, responsible for procurement operations at a biological production facility for raw materials. This role is crucial in ensuring a smooth supply chain transition from project phase to commercial production.
Manage procurement operations, ensuring timely ordering and delivery of materials.
Process purchase orders and monitor stock levels using SAP (MM module, client-side transactions).
Communicate with planning teams and suppliers to guarantee smooth supply chain operations.
Handle supplier negotiations related to delivery schedules and urgent needs.
Address quality investigations in coordination with suppliers and internal teams.
Serve as the main point of contact for operational procurement issues.
Ensure compliance with procurement processes and guidelines.
Your profile:
Bachelor’s degree in Sciences
Experience in procurement, supply chain management, or related fields.
Strong knowledge of SAP MM module (client-side transactions, order processing, stock management).
Excellent organizational and problem-solving skills.
Ability to work autonomously while being a strong team player.
Fluent in English and in French.
Strong communication skills to interact effectively with suppliers and internal stakeholders.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Our partner is seeking a highly motivated and experienced Consultant to lead an innovative automation project in the Global Quality Control (QC) area, specifically focusing on microbiology. The ideal candidate will have a strong background in automation, excellent communication skills, and the ability to write comprehensive user requirements. They will be responsible for exploring both external supplier solutions and internal potential solutions to enhance our QC processes. Additionally, they will need to prepare business cases with the help of different sites to support the project.
Your responsibilities?
1. Project Leadership:
Lead the automation project in the QC microbiology area from inception to completion.
Develop and maintain project plans and timelines
Coordinate with cross-functional teams to ensure project objectives are met.
2.Technical Expertise:
Utilize technical knowledge in automation to identify opportunities for innovative process improvements in microbiology.
Assess current QC microbiology processes and recommend automation solutions.
Stay updated on the latest advancements in automation technologies and their applications in microbiology.
Write clear and detailed use requirements for automation solutions.
Collaborate with stakeholders to gather and document functional and technical requirements.
Ensure that user requirements align with business objectives and regulatory standards.
Research and evaluate external supplier solutions for QC microbiology automation.
Conduct feasibility studies and cost-benefit analyses of potential solutions.
Explore and assess internal solutions and resources for automation implementation.
Prepare a comprehensive business case for the automation project with the assistance of different sites.
Collaborate with site representatives to gather data and insights to support the business case.
Present the business case to senior management and stakeholders to secure project approval.
Emphasize the innovative aspects of the project, exploring cutting-edge technologies and methodologies.
Identify and implement novel automation solutions that drive efficiency and effectiveness.
Your profile?
Bachelor’s degree in engineering, Automation, Microbiology, Computer Science, or a related field.
Proven experience in leading automation projects, preferably in a QC or pharmaceutical environment.
Strong technical knowledge of automation technologies and their applications (preferably in microbiology).
Excellent communication and interpersonal skills.
Ability to write comprehensive and detailed user requirements.
Experience in evaluating and selecting external supplier solutions.
Strong problem-solving skills and the ability to think critically.
Ability to work independently and manage multiple tasks simultaneously.
Experience in the pharmaceutical or healthcare industry is a big advantage
Knowledge of regulatory requirements related to QC microbiology processes.
Familiarity with project management tools and methodologies.
Fluent in French / English
What can you expect?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
Our partner is looking for a Lab Quality Coordinator to join its team.
Your responsibilities?
Lead Equipment management process
Be the SME on that process for the entire unit
Train the Asset owner from equipment purchase to equipment installed.
Be responsible for metrology aspect: Ensure mapping and reports delivered by the External vendors are compliant with the specificities defined by the Lab.
Ensure at least 1 internal Audit/year.
Be the responsible person for Clinical and Medical Controlled Document (CMCD) management: handle revisions, ensure CMCD compliance with the companies regulations and ISO17025 requirements.
Active member of Lab Quality meetings: act as strong advisor and lead project.
Ensure Audit and Inspection readiness.
Review study protocols and provide feasibility assessments on ability to perform laboratory requirements and procedures & ensure clinical trials are conducted according to the protocol requirement, objectives and timelines. Direct collaboration with the Laboratory team to execute and coordinate the qualitative actions within the framework ISO 17025.
Responsible for maintaining/demanding ISO17025 accreditation/certification of our Safety Laboratory.
Assures accurate collection and processing of biological specimens to assure quality of analytical data.
Integrate and monitor quality indicators (key performance indicator = KPI), handle non-conformities and claims as well as corrective and preventive actions. Follow-up of all discrepancies and close collaboration with Manager(s).
Define KPI’s for management review.
Your profile?
Engineering or scientific background (or equivalent acquired through professional experience)
Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
Knowledge of GMP / CFR / Eudralex …
Knowledge of different regulations and standards related to validation activities
Good communicator, autonomous and rigorous
Team player
Critical mind and quality oriented
Your profile?
• At least 3 years in Clinical Research or experience in analytical techniques and full knowledge of analytical validation procedure is required. Thorough knowledge of clinical pharmacology and regulatory requirements such as GCP, ISO17025 or at least ISO15189. • Good written and verbal skills in English, French and/or Dutch are essential • Flexible: Demonstrate ability and flexibility (regular on-call duty, 24/7) in case of urgency to ensure safety coverage of volunteers/patients and clinical trials.
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Your responsibilities: As a Gene Therapy Quality Partner, you will support the Genesis project GMP Readiness program to timely obtain health authorities authorization to manufacture Gene Therapy clinical batches in the new facility pilot plant.
Drive the implementation of the new Gene Therapy facility quality operational procedures into existing QMS (change control, deviation management, release procedures, training, etc).
Support the documented assessment of the GMP & Operations Readiness program progresses according to project key milestones.
Support management of materials & product specifications, execute incoming materials release
Support the consolidation and writing of the Contamination Control Strategy
Drive the supplier’s qualification program
Establish and drive the inspection readiness program
Drive the preparation of the new Gene Therapy Facility Site Master File
Your profile:
Scientific master’s degree or equivalent
At least 5 to 8 years of experience of QA oversight in a GMP manufacturing environment
Experience of a new manufacturing facility seeking Health Authorities certification
Good knowledge of Biopharmaceuticals or Gene Therapy manufacturing
Experience in health authorities’ inspections
Strong Knowledge of GMP, CFR, Eudralex for Biopharmaceutical manufacturing
Fluency in English and French
QP Registration in Belgium is an asset
Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
Strong understanding of a risk-based approach
Able to understand customers’ needs and technical requirements
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Development of an in-depth understanding of the process chemistry and process engineering relating to the postholder's projects and an awareness ofchemical aspects of other projects within the group.
Execution of preliminary literature surveys leading to the definition of experimental programs. Planning, preparation and implementation of experimentaland/or scale-up studies using standard and specialized equipment and techniques(laboratory, kilo-lab & pilot plant). Initiation, monitoring and work-up of reactions aswell as isolation and purifications of materials (laboratory, kilo-lab and pilot scale).
Identification and definition of specific analytical tests in order to facilitate effective process development and ensure optimum product quality. Submission ofmaterials for analysis and/or generation of analytical data using standard laboratoryanalyses. Interpretation of analytical results from these tests for laboratory, kilo-laband pilot activities.
Ensuring good record keeping with respect to all laboratory, kilo-laboratory and pilot plant activities, particularly regarding patentability & regulatory requirements.
Preparation of detailed reports covering specific work programs on completion of the activities or whenever appropriate. Preparation of high quality documentationin support of potential companies patent applications and other publications as requested.
Participation in the transfer of chemical processes from laboratory to kilo-lab, pilot plant and/or production, under the direction of Science lead.
Full compliance with all departmental and site-specific Health, Safety,
Environmental and Quality regulations, systems and procedures covering laboratoryand scale-up activities. Additional requirement of full compliance with all companies business policies and guidelines.
Participation in and active contribution to departmental and/or technical meetings as required. Responsibility for ensuring compliance with actions established during these meetings.
Participation in, contribution to and/or completion of other initiatives, tasks or activities as requested or assigned by the project/science lead, group head, or department Director from time to time
Your Profile
Knowledge in general organic chemistry both theoretical and practical;chromatography (HPLC/UPLC/GC) and characterization techniques (UV; PAT;NMR and MS spectrometry); Automatized equipment, typical lab equipment.
Knowledge in process analytical technology (PAT) for monitoring and characterization
Knowledge in crystallization process development and characterization
Ability to participate to process development as scientist in specific area of expertise as process characterization, optimization, understanding, industrialization and investigation QbD development of the different compounds in development.
Experience in ensuring that all developed processes can be scaled up to a 60 L reactor and perform the syntheses at this scale in the Kilolab.
Experience in transferring to the Pilot Plant is an asset
Understanding of regulatory environments
Good understanding of the results, good record keeping and reporting with respect to technical activities.
Ensure that all processes are in compliance with internal safety rules.
Ability to ensure a good literature survey on the projects by using all available research methods and tools.
Ability to find technical solutions and activate all appropriate internal /external experts to solve the issue
Ability to independently manage R&D tasks in order to meet deadlines within given constraints in resources, e.g. headcount, equipment, time, etc.
Demonstrated flexibility and agility to learn and acquire new competencies
Demonstrated ability to participate in the communication and information exchange
Demonstrated good interpersonal, verbal, and written communication skills with ability to balance multiple priorities
Work transversally across projects and groups in line with the needs of the business and as part of the Drug Substance Process Sciences organization and wider CMC
Our offer Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Your responsibilities: Our client is looking for a Documentation & Training Coordinator for a major project aimed at modernizing the artwork management system. This role is crucial to ensure the update and finalization of associated documentation, as well as the coordination of training for users. The person hired will work closely with a dynamic project team.
Coordinate the update of documentation according to the new defined structure.
Support Subject Matter Experts (SMEs) to ensure the timely delivery of documents.
Monitor and manage the documentation schedule.
Plan and organize the user training program (300+ people).
Ensure adherence to the schedule and follow up with stakeholders in case of delays.
Coordinate the transition period between the old and new systems.
Ensure smooth communication with the various teams involved.
Your profile:
Bachelor's Degree in Sciences
Fluency in French and English, Dutch is a plus.
Experience in documentation coordination for large projects.
Excellent organizational skills and strong responsiveness.
Diplomacy and ability to bring stakeholders together.
Advanced proficiency in Excel and project management tools.
Project management experience (without being a Project Manager) is a plus.
Experience in the pharmaceutical or regulated industry is a plus but not required.
Our offer: Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Are you interested in the pharmaceutical industry and putting your knowledge of validation to good use? Our client is actively looking for a QA Validation Specialist to strengthen its activities.
What are your responsibilities? As QA Validation Specialist, you are in charge to :
Responsible for the coordination of the validation of small projects Primary industrialization or Secondary (Formulation or Filling) or QC streams related to equipment such as freeze dryer, autoclaves, oven…or CIP, SIP,Mediabulk, Mediafill, Mediaform or utilities or process control/automation equipment.
Responsible for defining and implementing an adequate validation strategy in compliance with FDA, EMEA and International quality standards.
Responsible for ensuring and coordinating the support (planning, weekly validation, resources, cost) to RPCs or projects
Responsible for VMP (Validation Master Plan)
Review and approve protocols and certificates for IQ/OQ/PQ and check-lists
Write QSR (Qualification status report)
Manage deviations and out of specifications: bring expertise and help in investigating and solving issues
Ensure correct and state of the art Validation approaches for RPC from Design Qualification step to the establishment of the Qualification Summary report (which is final approved by the QA). This accountability involves knowledge of the Validation Life-cycle process as well as in Specific Validation Strategies (i.e.Cleaning Validation, Aseptic Media Simulation…)
Participate as expert in external authorities inspections
Responsible for assuring inspection readiness – regarding Validation – by Corporate functions and RA authorities
Bring expertise and coaching to streams
Project Management: control/monitor cost and planning. Take corrective actions if necessary.
Ensure coordination with all key players (local QA, Global QA, C&M, Streams rep,…)
Who are you?
You are graduated as a Pharmacist’s degree or a Master Science.
Expertise in validation, knowledge of International standards (CFR and Eudralex), GMP and Regulatory
Successful experience in people management
At least 5 years experience in aseptic processing or vaccine production
You fluently speak French and English.
What can you expect? A permanent contract is offered for this function with a salary package matching your skills & experience. The opportunity to develop your skills or to evolve within this company is also open. You’re interested in this job? We kindly invite you to apply !
