Process Engineer Brabant Walloon – contracting Our partner is looking for a Process Engineer to join its team. This international company is well-known for its pharmaceuticals. Your responsibilities? In coordination with Engineering Office and Project Management, you will provide expertise in the implementation of good engineering & design practices and solutions to support design, execution and commissioning / qualification phases of CapEx Projects. You will ensure correct design, construction, commissioning, and qualification in full compliance with internal requirements and authorities' requirement of Secondary equipment’s and Aseptic technologies package. Related to these packages, it includes:
Being the internal representative for all Secondary equipment’s and Aseptic technologies-related activities and installations
Supporting the E.O in management of activities related to this package
Ensuring alignment between E.O and the company Specification and Guidance
Reviewing design and technical documentation
Following-up construction & all testing activities falling under the package’ scope
Ensure systems start-up and punch list solving
Writing and executing commissioning and qualification protocols/reports
Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities.
Facilitating handover process towards the end user
Your profile?
Engineering degree with 5 years’ experience as Process Engineer in Secondary Equipment’s and Aseptic Technologies domains.
Strong Experience in the Pharmaceutical industry and cGMP environment.
Definition of functional, technical and quality requirements.
Realization of reviews of process studies, P&ID’s and layouts
Oversight contractor's performance.
Integration of operability and EHS requirements at all design steps.
Preparation of the project testing, commissioning and inspection requirements
Organize legal conformity visits
On-site verification of execution according to good practices
Coordination with suppliers representatives, MPU representatives (User, QA, Validation, Maintenance,…),..
Team working & Communication, Autonomy, Contractors' management.
Good project integration experience: organisation, schedule, qualification, validation, technologies.
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. Do you have any questions? You can contact Anaïs Malikian, [email protected]
Our partner is Belgium's high-voltage electricity transmission system operator. Based in Brussels, they are looking for a Project Engineer Civil Works Service
Your responsabilities
Develop technical solutions during the design phase
Prepare and manage project budgets.
Provide input for scheduling and defining the work scenarios for the project and coordinating with other projects.
Coordinate and follow up on architectural plans for permit applications.
Manage, coordinate, control, and follow up on execution studies, including the structural stability studies of civil constructions and the preparation of plans.
Inform designers during the detailed study phase about the technical requirements of the project, ensuring correct execution of the scope.
Supervise and monitor external engineering partners.
Draft the technical specifications and bill of quantities for contractor selection.
During the execution phase, support the project manager in resolving specific technical issues.
Collect feedback and organize the final review of the completed study. Provide input for the acceptance of works.
Take full responsibility for the quality of civil engineering studies
Your profile
Excellent knowledge of Dutch and French
Degree in Civil Engineering or equivalent
Strong focus on quality
Well-organized, flexible, with strong communication skills and a team-oriented mindset
Strong affinity with construction techniques, soil mechanics, and knowledge of structural stability calculations
Capable of managing several projects simultaneously
Proactive in project task management and problem-solving approach
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? Don't hesitate to apply
Be the central QA point of contact for the organization for investigations/deviations/ out-of-specifications/ audit observations associated with the assigned vendors. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders (Vendor Team, GQL, CAS, Business) to allow assessment.
Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools (Vendor QA KPI tracker, QuickScore) and track the vendor’s performance
Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product GQLs and the vendors.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the Controlled Documents System.
Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings
Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
If needed work with the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Corporate Technical Review (CTR) meeting. Coordinate vendor quality related investigations
Participate on ad-hoc basis to the Product Change Control Committees for activities related to the vendors
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors
Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way
Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors
Developer and owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors
Ensure all relevant documentation are provided to the vendors and implemented (Methods, Specs, Master Batch record)
Ensure review of relevant RA dossier section related to the assigned vendors
Have the overview of audit and HA inspections related to the vendors. Track and follow-up on Audit observation and CAPA plan implementation at the vendor.
Be the QA stakeholder for Vendor Risk management.
Manage and control quality documents related to the vendors in the Controlled Documents System
Support on customer audits and Health Authority inspections at the vendors, as needed
Receipt, coordinate review and authorize product reworks and repackaging.
Drive resolution for complex quality issues related to the vendors in scope including coaching other VQL’s on problem solving for complex issues. Be the point of contact for critical post-release vendor issues (supply chain, distribution, etc.). Challenge current practices for issue resolution and incorporate new perspectives into existing problems.
As required provide Operational QA support to vendors for process, equipment and facilities qualification and project support
Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development.
Acts as a coach for VQL’s with less experience.
Acts as a Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process
Act as coach for the direct reports, perform personal development discussions and manage year-end evaluations and objectives setting (if applicable).
Oversee the VQL activities performed by the direct reports (if applicable).
Your profile:
Master's Degree in Sciences
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
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.
Possess good auditing capabilities and skills
Must have the ability to manage projects/ activities across global geographies within the area of expertise.
Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
Root cause and risk management/assessment skills Problem Solving (Describe the level of “self-starting” thinking required in the for recognizing, analyzing and solving problems)
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]
Autonomously manage and execute daily laboratory activities related to method development, validation, and transfers.
Contribute to release and stability testing in relation to the project, as appropriate.
Prepare, review, and approve documentation (procedures, protocols, reports).
Analyze experimental results.
Verify data accuracy.
Present and discuss results in project team meetings.
Perform all activities in compliance with GMP/HSE rules and regulatory requirements for each development phase of the product.
Your Profile
Master’s or Bachelor’s degree in biochemistry or analytical chemistry.
Proven expertise, preferably in the biotech industry.
Strong, proven laboratory skills.
Good knowledge of protein chemistry and techniques for separating polymers in a protein matrix.
Practical experience and expertise in at least one of the following analytical techniques:
Chromatography (Size-exclusion, Reverse-phase, Affinity, Ion exchange, HILIC, or HIC).
Electrophoresis (Capillary: CGE, CzE, iCE, or MauriCE).
Expertise in analytical method development and validation.
Ability to work autonomously in day-to-day tasks.
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
A good knowledge of GLP/GMP rules is a plus.
Good English skills (both written and oral) are recommended for reports and communication.
Ability to manage multiple priorities and prioritize effectively.
Strong interpersonal skills to communicate and maintain good working relationships within the team and with internal/external customers/partners.
Ability to work in a matrix and customer-oriented environment.
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]
Primary packaging systems innovation and new products development management :
New primary packaging systems development management in line with the strategy, “Pipeline Devices & Delivery Systems” and technologic/scientific platforms objectives and according to established working processes.
Clinical medical devices design and assessment
Primary packaging systems life cycle & sustaining management :
Primary packaging systems sustaining and life cycle management coordination and support to all operation sites and CMO’s.
Competitors pharmaceuticals primary packaging systems benchmarking management :
Competitors primary packaging systems portfolio analyze & characterization.
Primary packaging materials, components and technology scouting and assessment according to defined priorities
Planning, implementation and documentation to maintain and set up the systems (processes, resources, equipment) of the organizational unit
Where applicable: maintenance of and responsibility for the SOP processes assigned to the unit and direct sub-processes thereof
The job holder informs his superior about significant changes and progress without delay on a regular basis and in emergencies.
Within the unit and/or projects the job holder ensures that the internal regulations and the national laws and ordinances concerning occupational safety, accident prevention, waste removal and disposal, and environmental protection are observed
In the planning, performance and documentation of his work within the unit the job holder ensures that the applicable internal rules (Standard Operating Instructions, SOP) and the applicable national and international laws, regulations and directives are observed
The job holder participates in the necessary training defined for his job, e.g. SOP training sessions, GMP training sessions, projects management, technical/scientific trainings, conferences, etc
Your profile:
Minimum of 5 years working in the pharmaceutical/biologics/medical primary packaging industry. Operational GMP or quality experience would be a distinct advantage
Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements, USP, Ph.Eur. and JP standards, Food-contact legislations
Knowledge of Good Manufacturing Practice (e.g. ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations in the field of primary packaging raw materials, components and systems
Pharmaceutical business experience and familiarity with competitive landscape of primary packaging development process, regulatory requirements
Experience in global projects, ideally with USA or EU operational, HS&E processes and procedures
Proven track record in project management / Project Management certification will be a distinct advantage
Fluency in French & English
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]
Beschik je over een passie voor kwaliteit? Heb je werkervaring met kwaliteitsbewaking in de maakindustrie? Heb je kennis van ISO-normen en werk je gestructureerd en oplossingsgericht? Lees dan vooral verder!
Onze partner is op zoek naar een Quality Engineer om hun kwaliteitsteam binnen de staalafdeling te versterken. Dit internationaal gerenommeerd productiebedrijf, gelegen in de regio Brugge, is wereldwijd actief binnen de automobiel- en industriële sector en staat bekend omwille van hun innovatieve technologieën en focus op duurzaamheid en kwaliteit.
Jouw verantwoordelijkheden?
Als Quality Engineer kom je terecht in een kwaliteitsgerichte en technisch uitdagende omgeving. Je krijgt de verantwoordelijkheid over het ondersteunen van de productieactiviteiten met een sterke focus op kwaliteit. Jouw takenpakket bestaat uit een aantal gevarieerde activiteiten: • Zorgen voor naleving van relevante normen zoals ISO 9001, ISO 14001 en ISO 45001 • Implementeren en verbeteren van SPC en MSA in de CNC-afdeling • Beheren van leveranciers, inclusief klachtenopvolging en evaluatie van 8D-rapporten • Onderhouden van contacten met externe kwaliteitsdiensten • Opstellen van kostentoewijzing per leverancier voor de financiële afdeling • Opstellen van KPI-rapporten, Pareto-analyses en kostenanalyses
Wie ben je?
Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als Quality Engineer over een bachelor diploma in een technische richting, aangevuld met minstens 3 jaar relevante ervaring binnen een kwaliteitsfunctie. Ervaring in een CNC-omgeving is een pluspunt. Je kan vlot technische tekeningen lezen en beschikt over een grondige kennis van meet- en controletechnieken.
Je hebt ervaring met kwaliteitsinstrumenten zoals SPC, FMEA, APQP en PPAP. Je bent communicatief vaardig in het Nederlands en Engels – dit is een absolute vereiste. Daarnaast werk je autonoom, gestructureerd en weet je vlot om te gaan met stressvolle situaties. Tot slot ben je een teamspeler met een hands-on mentaliteit en analytisch denkvermogen.
Wat kan je verwachten?
Als Quality Engineer kom je terecht in een dynamische en open werkomgeving met aangename collega’s. Bovendien krijg je een aantrekkelijk salarispakket aangevuld met extralegale voordelen en een onmiddellijk vast contract van onbepaalde duur. Ten slotte krijg je de kans om je professioneel en persoonlijk verder te ontwikkelen via interne opleidingen en doorgroeimogelijkheden binnen een stabiele en groeiende organisatie.
Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Jan Van Grembergen op het nummer +32 (0)494 16 31 09 of via [email protected].
Your responsibilities: Support the Quality SPOC for selected contractors / suppliers (in transfer or in commercial operations) for:
Ensuring that Quality systems are in place/in use, routinely monitored and assessed
Mastering quality agreement content
Releasing validation and/or commercial batches, including production and Quality control documentation, within the time frame defined by submission or Market needs and in compliance with regulatory files, good manufacturing practices and regulatory requirements, certify release process and evaluate regularly the certification status
Ensuring all quality activities linked to the contractor / supplier management (deviations, CAPA closure, change control, risks management, complaints, product quality review, …)
Ensuring and maintain good relationships with the contractor in order to guarantee win-win collaboration, through informal meetings and governance meetings.
Representing the QA External Manufacturing within various governance meetings and timely escalate issues to Manager if required by internal process
Identifying risks associated to the specific activities of the CMO
Driving continuous improvement projects with CMO and with internal and external stakeholders (Operations, Technical group, etc.) in order to strengthen the manufacturing activities
Your profile:
University Scientific background (Pharmacist, Phd in life sciences, Bio Engineer …).
Min. 5 years of experience in Pharmaceutical Industry associate with a GMP background
Experience as in QA or production department, with expertise on the field, in quality systems or release. SAP experience is mandatory (deviation, CC, CAPA, …).
Good knowledge of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
Fluent in English and French
Excellent communication (including presentation) and influencing skills.
Stakeholders’ management: ability to interact with internal & external stakeholders
Ability to travel to CMO (less than 1x/2month)
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 Bornem #elektriciteit #automatisatiesystemen #R&D
Beschik je over een master in een technische richting? Heb je werkervaring met het implementeren en designen van elektrische installaties? Heb je oog voor detail en werk je graag in een internationale context? Lees dan vooral verder!
Onze partner is op zoek naar een Electrical Engineer om hun globale automatisatieteam te versterken. Dit internationaal toonaangevend productiebedrijf, gelegen in regio Bornem, is wereldwijd actief in de farmaceutische en life sciences sector en staat bekend omwille van hun innovatieve technologieën en hoge kwaliteitsstandaarden.
Jouw verantwoordelijkheden?
Als Electrical Engineer kom je terecht in een hoogtechnologische en internationale omgeving en krijg je de verantwoordelijkheid over het ontwerpen, implementeren en aanpassen van elektrische systemen voor productievestigingen wereldwijd. Jouw takenpakket bestaat uit een aantal gevarieerde activiteiten:
Ontwerpen en modificeren van bestaande automatisatiesystemen op basis van P&ID’s, functionele eisen en elektrische schema’s.
Onderhouden van technische documentatie zoals elektrische tekeningen, IO-lijsten en BOM’s.
Actief deelnemen aan de opstart (commissioning) en validatie van systemen.
Ontwikkelen en onderhouden van wereldwijde standaarden voor elektrische systemen in lijn met internationale regelgeving.
Fungeren als contactpersoon tussen R&D en productie om elektrische integratie te stroomlijnen.
Samenwerken met interne en externe stakeholders om nieuwe technologieën te implementeren.
Voorzien van projectinschattingen qua tijd en kosten voor elektrische hardware en testing.
Ondersteunen van een veilig en milieubewust werkklimaat.
Wie ben je?
Om bovenstaande taken en verantwoordelijkheden succesvol uit te oefenen, beschik je als Electrical Engineer over een bachelor of master in elektromechanica of elektrotechniek, aangevuld met minstens 5 jaar ervaring in een productieomgeving. Ervaring binnen een gereguleerde sector zoals farma of voeding is een pluspunt. Je bent communicatief vaardig in het Engels, zowel gesproken als geschreven. Daarnaast heb je een analytische en nauwkeurige ingesteldheid en ben je zelfstandig maar ook een echte teamspeler. Tot slot ben je ook een praktische en oplossingsgerichte persoon met sterke project- en documentatievaardigheden.
Wat kan je verwachten?
Als Electrical Engineer kom je terecht in een dynamische en open werkomgeving met aangename collega’s. Bovendien 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 via 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 [email protected].
Location:Brabant Wallon, Région wallonne, Belgique
Job#25834
Qualification-Validation CSV Engineer
Contracting – Brabant Wallon
Vos responsabilités :
Définir et assurer le suivi des stratégies de qualification/validation CSV dans le respect des Bonnes Pratiques de Fabrication et des règles d'hygiène et de Sécurité et conformément au Validation Master Plan du projet.
Evaluer l’impact qualification inhérent aux risques identifiés.
Rédiger les documents de qualification conformément aux SOP de qualification / validation.
Identifier l’approche d’implémentation de ces stratégies (Change Control, autres) dans le cadre du projet.
Planifier, organiser et coordonner les activités de validation, en lien avec l’équipe projet.
Exécuter et/ou vérifier les tests de qualification / validation des installations en impliquant les futurs utilisateurs et conformément aux procédures en vigueur.
Reporter à sa hiérarchie tout problème ayant un impact sur le planning d’implémentation
Donner le support CSV aux activités de l’équipe (gestion de déviations, CAPA, préparation et/ou participation aux audits, …).
Mettre à profit son expertise CSV afin de répondre à des sujets spécifiques (position papers, analyses de risque, …)
Garantir l’auditabilité permanente des dossiers de validation et de qualification des installations
Votre profil :
Bachelor / Master de préférence à orientation informatique/automation industrielle et autrement, dans un domaine scientifique.
Plus de 5 ans d’expérience dans le domaine de la validation dont au moins 3 ans sur les systèmes automatisés et/ou informatisés et en particulier sur des mises à jour / upgrade / revamping de software / firmware.
Compréhension des flux, des pratiques, des méthodologies et des délivrables de validation.
Connaissance confirmée de la partie automation des procédés industriels pharmaceutiques (laveuses, bioréacteurs, autoclave, testeurs de filtres, stations CIP/SIP, biowastes, …).
Connaissances des paramètres et éléments de conception pouvant avoir un impact qualité sur les procédés susmentionnés.
Connaissance des techniques en IT/Computer System Validation.
Bonne connaissance de PCS7
Compréhension et facilité d’expression en anglais.
Capacité à prendre des responsabilités et des décisions.
Rechercher et analyser les causes de défaillances, et proposer des solutions innovantes pour y remédier.
Notre offre : Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations sur des sujets techniques ainsi que sur les soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours. Vous êtes intéressé par ce poste ? Nous vous invitons cordialement à postuler ou à m'envoyer votre CV à l'adresse suivante : [email protected]
Review of product marketing materials to ensure conformity with product claims.
Monitor and communicate regulatory requirements to ensure preparedness for upcoming submissions.
Provide regular updates on the project's progress to internal stakeholders.
Your profile?
Advanced degree in life sciences (e.g., veterinary medicine, toxicology, pharmacy, chemistry, etc.) or equivalent.
Previous experience in Regulatory Affairs (minimum of 1 year on drafting of regulatory documents)
Experience liaising with Health Authorities
In-depth knowledge of the regulatory environment and guidelines.
Experience with generic medicines is an asset.
Good planning and organizational skills
Strong interpersonal communication skills (verbal and written).
English and French 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.
