Job Category : Life Sciences

Validation Engineerig

  • Location: PUURS
  • Job #27541

Validation Engineer
Contracting – Antwerp
 

Belangrijkste verantwoordelijkheden

  • Uitvoeren van compliance-beoordelingen van dossiers voor methodevalidatie en compendiale conformiteit.

  • Ondersteunen van de implementatie van nieuwe testmethoden en analytische procedures binnen Quality Control Operations.

  • Coördineren en plannen van projectactiviteiten met betrekking tot laboratoriummethode-implementatie en validatie.

  • Schrijven en beoordelen van protocollen, testscripts en technische rapporten.

  • Beheren en documenteren van analytische afwijkingen, inclusief onderzoek en opvolging.

  • Beoordelen van validatie- en methodetransfer-testresultaten om naleving van regelgeving en kwaliteitsnormen te waarborgen.

  • Valideren van analytische databestanden en ondersteunende documentatie (bijv. SoftMaxPro, Excel).

  • Verifiëren van naleving van farmacopoeiale (compendiale) testvereisten.

  • Technische ondersteuning bieden aan QC-analisten tijdens de uitvoering van methoden.

  • Oplossen van laboratoriumproblemen en uitvoeren van root cause-analyses met behulp van methodologieën zoals DMAIC.

  • Deelnemen aan onderzoeken naar analytische afwijkingen, het bepalen van de hoofdoorzaken en het implementeren van corrigerende en preventieve maatregelen (CAPA).

  • Ondersteunen of mede-auteur zijn van regelgevende indieningen voor nieuwe geneesmiddelen of vaccins wanneer vereist.

  • Bijdragen aan initiatieven voor continue verbetering binnen laboratorium- en QC-processen.

Kwalificaties

  • Masterdiploma in Industrieel Ingenieur, Burgerlijk Ingenieur, Bio-ingenieur, Industriële Farmacie, of een wetenschappelijke richting zoals Biochemie of Biotechnologie.

  • Vloeiend in het Nederlands en goede kennis van het Engels (schriftelijk en mondeling).

  • Sterke vaardigheden in technisch schrijven en documentatie.

  • Uitstekende communicatie- en organisatorische vaardigheden.

  • Hoge mate van nauwkeurigheid en oog voor detail.

  • Sterk analytisch denkvermogen en probleemoplossende vaardigheden.

  • Ervaring in een GMP-gereguleerde omgeving is sterk gewenst.

  • Vermogen om effectief te werken in een crossfunctionele teamomgeving.

  • Meerdere jaren relevante ervaring binnen een farmaceutische, laboratorium- of productieomgeving wordt als een pluspunt beschouwd.

Laboratory Operations Project Engineering II

  • Location: PUURS
  • Job #27540

Laboratory Operations Project Engineer
Contracting – Antwerp

Key Responsibilities
Method Validation & Compliance

Perform compliance assessments of method validation and compendial compliance dossiers.

Review validation and method transfer test results to ensure regulatory compliance.

Verify compendial test methods and ensure proper implementation within QC operations.

Validate supporting data files and tools (e.g., SoftMaxPro, Excel).

Project Coordination & Implementation

Coordinate and plan activities for the implementation of new analytical methods and procedures.

Ensure proper documentation and adherence to internal procedures and GMP requirements.

Collaborate with cross-functional teams to ensure timely execution of projects.

Documentation & Reporting

Write and review validation protocols, testing scripts, and technical reports.

Manage and document analytical deviations according to quality procedures.

Support regulatory documentation and may co-author submissions for new medicines or vaccines.

Investigation & Problem Solving

Investigate analytical deviations and laboratory issues efficiently and thoroughly.

Perform root cause analysis using structured methodologies such as DMAIC.

Initiate and follow up corrective and preventive actions (CAPA) to resolve quality-related deficiencies.

Operational Support

Provide technical support to QC analysts during test execution.

Conduct troubleshooting of analytical methods and laboratory equipment issues.

Contribute to continuous improvement initiatives within laboratory operations.

Qualifications
Education

Master’s degree in:

Industrial Engineering, Civil Engineering, or Bio-Engineering

Industrial Pharmacy

Biochemistry, Biotechnology, or a related scientific field

Experience

Several years of relevant experience in a pharmaceutical, biotechnology, or production environment is preferred.

Experience working in a GMP-regulated environment is strongly desired.

Skills & Competencies

Strong technical writing skills for protocols, reports, and validation documentation.

Excellent analytical and problem-solving abilities.

Strong communication skills (written and verbal).

High level of accuracy and organizational ability.

Team player with strong interpersonal skills.

Languages

Fluent Dutch (written and spoken).

Good command of English (written and spoken).

 

Digital Lab System Support

  • Location: geel
  • Job #27526
 

Lab Systems Support Specialist
Contracting – Antwerp
Functieomschrijving:
Verantwoordelijk voor operationele ondersteuning, lifecycle management en IT-infrastructuur van gecomputeriseerde labsystemen binnen QC, MSAT en productie, zowel in GMP- als non-GMP-omgevingen.
Belangrijkste taken:

  • Beheren van de volledige lifecycle van labsystemen: ontwerp, implementatie, onderhoud en afbouw.
  • Ontwikkelen, implementeren en onderhouden van installatieprocedures en architectuurspecificaties.
  • 2e en 3e lijns ondersteuning bieden, inclusief troubleshooting, prestatieanalyse en onderhoud van systemen.
  • Backup-, herstel- en disaster recovery-plannen opstellen, onderhouden en testen.
  • Ondersteunen van validatie- en kwalificatieactiviteiten; waarborgen van GMP-compliance en data-integriteit.
  • Samenwerken met interne stakeholders (QC, MSAT, productie, QA, Validatie) en leveranciers; contacten onderhouden met internationale collega’s.
  • Documenteren van technische specificaties en kennisdeling binnen IT, QA en Validatie.

Vereiste kwalificaties:

  • Technische kennis: Windows 10/11, Server 2016/2022, TCP/IP, Active Directory, antivirus, remote administration, scripting (DOS, VBScript, PowerShell).
  • Ervaring met installatie, troubleshooting en onderhoud van Microsoft-systemen.
  • Kennis van GMP, GAMP5, CFR 21 Part 11 en validatie/kwalificatie-methodologie.
  • Nauwkeurig kunnen schrijven van technische specificaties en installatie-instructies.
  • Sterke communicatieve vaardigheden en servicegerichte houding.
  • Zelfstandig én in teamverband kunnen werken; initiatief nemen.
  • Vloeiend in Nederlands en Engels.

Pré-kwalificaties:

  • Ervaring in een vergelijkbare GMP lab systems support rol.

Vendor Quality Lead

  • Location: Braine-l'Alleud
  • Job #27518

Vendor Quality Lead
Contracting – Walloon Brabant

Our partner is currently looking for a Vendor Quality Lead to join its team. This international company is well-known for its pharmaceuticals. 

What are your responsibilities?
 This position will provide leadership and in-depth QA expertise in driving strategic and operational Quality Assurance activities associated with complex Global Vendors (Contract Manufacturing Organizations) engaged in GMP manufacturing activities for the company Products.

Vendor Quality Lead (VQL) related accountabilities:

  • 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 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 vendors.
  • When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the company Stability Program
  • Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed and are reviewed within the requested time period. Ensure that this review is documented and made available in the internal 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 company Complaint System and provision of responses to the complainant are professionally coordinated and managed.
  • If needed work with the Vendor team and CMC 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 company Product Change Control Committees for activities related to the vendors
  • Provide in-depth expert QA advice, support and management for technical operational QA and general QA strategic matters associated with the vendors
  • Work closely with Global 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 the company 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 other vendors
  • Act as substitute for other Vendor Quality Leads in times of absenteeism (e.g. vacation, illness)
  • Acts as a coach for VQL’s with less experience.
  • Work in accordance with internal 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 Best Practice ambassador, leads best practices steams and uses knowledge of internal/external business environment to improve existing process.

Who are you?

  • Master’s degree in Life Sciences, Engineering, or a related field
  • Experience in Quality Assurance.
  • Experience in vendor management.
  • Experience with Quality Management Systems (QMS) in pharmaceutical manufacturing environments.
  • Knowledge of aseptic manufacturing processes.
  • 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 work independently and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
  • Possess good auditing capabilities and skills.
  • Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
  • Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
  • Root cause and risk management/assessment skills

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.

New Product Introduction Project Engineer

  • Location: PUURS
  • Job #27513

New Product Introduction Project Engineer
Contracting – Antwerp

Verantwoordelijkheden:

  • Valideer en documenteer ondersteuning voor formulering-, vul-, verzend- en verpakkingsprocessen.
  • Voer dringende kwaliteitsonderzoeken uit en documenteer deze.
  • Voer uitgebreide risicoanalyses uit en bepaal passende mitigerende maatregelen.
  • Ondersteun en implementeer proces- en systeemwijzigingen in verband met productintroducties.
  • Zorg voor algemeen projectmanagement, inclusief coördinatie, planning, probleemoplossing en voortgangsrapportage.
  • Werk samen met cross-functionele teams om afstemming en naleving van projecttijden te waarborgen.

Profiel:

  • Masterdiploma in een wetenschappelijk vakgebied zoals Bio‑ingenieurswetenschappen, Farmacie, Biochemie of Biotechnologie.
  • Uitstekende beheersing van het Nederlands en goede beheersing van het Engels (schriftelijk en mondeling).
  • Sterke communicatieve en interpersoonlijke vaardigheden; teamgericht met het vermogen om zelfstandig te werken.
  • Zeer georganiseerd, nauwkeurig en kwaliteitsbewust in de werkhouding.
  • Sterke analytische vaardigheden, probleemoplossend vermogen en vaardigheid in technisch schrijven.
  • Ervaring met het uitvoeren van validatieprojecten en projectcoördinatie wordt sterk gewaardeerd.
  • Pragmatisch, proactief en resultaatgericht met het vermogen om initiatief te nemen.
  • Ervaring in een Good Manufacturing Practices (GMP) omgeving en bekendheid met risicoanalyse- en validatieprocessen.
  • Flexibiliteit voor ploegendiensten kan vereist zijn, afhankelijk van de projectbehoeften

 

Project Engineer Site Tech Services

  • Location: PUURS
  • Job #27504

Project Engineer Site Technical Services
Contracting – Antwerp

Taken
• Bieden van technische en projectmatige ondersteuning om een robuuste farmaceutische productie van Medical Devices en Combination Products (MDCP) te waarborgen.
• Ondersteunen van product lifecycle activiteiten zoals productlanceringen, technische onderzoeken, change management en continue verbetering.
• Uitvoeren en ondersteunen van technische onderzoeken en probleemoplossing binnen productieprocessen.
• Beheren of ondersteunen van technische verbeter- en implementatieprojecten.
• Ondersteunen van design- en proceswijzigingen en uitvoeren van bijhorende risicoanalyses.
• Zorgen voor naleving van GMP-richtlijnen en interne kwaliteits- en regulatoire vereisten.
• Ondersteunen bij het onderzoek van klantklachten en implementeren van corrigerende en preventieve acties (CAPA).
• Samenwerken met Manufacturing Quality Assurance bij de behandeling van Non-Conformance Reports (NCR) en de kwalificatie van materialen en processen.
• Leiden of ondersteunen van technische projecten inclusief planning, risicoanalyse en uitvoering.
• Voorbereiden en onderhouden van technische documentatie zoals protocollen, rapporten en risicoanalyses.
• Ondersteunen van productlanceringen, line extensions en marktuitbreidingsactiviteiten.
• Coördineren met Operations, Engineering, QA en leveranciers om een tijdige uitvoering van activiteiten te garanderen.
• Identificeren van technische risico’s en bijdragen aan continue verbeteringsinitiatieven.
• Samenwerken met productie, R&D, Quality en Regulatory Affairs binnen product- en proces lifecycle management.

Profiel
• Masterdiploma in Engineering (Mechanisch, Biomedisch, Chemisch, Manufacturing) of gelijkwaardig door ervaring.
• Ervaring in farmaceutische of medische hulpmiddelenproductie of technische projectondersteuning is een pluspunt.
• Goede kennis van GMP en kwaliteitssystemen.
• Sterke analytische vaardigheden en probleemoplossend vermogen.
• Goede projectmanagement- en organisatorische vaardigheden.
• Sterke communicatieve vaardigheden en teamgerichte houding.
• Nauwkeurig, kwaliteits- en veiligheidsgericht.
• Vlotte kennis van het Engels, kennis van het Nederlands is een plus.

Nice to have
• Kennis van 21 CFR Part 820, ISO 13485 en ISO 14971.
• Ervaring met medical devices of combinatieproducten.
• Ervaring met injection molding technologieën binnen de medische sector.

 

QA Systems Officer Utilities

  • Location: Braine-l'Alleud, Région wallonne, Belgique
  • Job #27502

QA Systems Officer Utilities

Contracting – Brabant Wallon

Your responsibilities:
General QA Role

  • Ensure compliance with all relevant regulatory requirements
  • Organize adequate quality oversight on GMP documentation and activities.
  • Promote leading and proactive management of deviations, corrective and preventative actions and change controls.
  • Actively participate to the quality governance in place within the organization.
  • Ensure appropriate quality indicators are monitored (both leading and lagging) and adhered to.
  • Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS.
  • Participate in the preparation for regulatory inspections, providing direct support to system owners and main customers during inspections.
  • Promote strong communication within Quality teams and strive for reducing variability to aim for One Quality Voice.
  • Foster a culture of quality, compliance, and continuous improvement within the organization.

Beltech Utilities support

  • Together with BIM Teams, ensure direct follow-up of Compliance Audit activities, Deviations, Failure Investigations, Change Control, Qualification/Validation activities and associated documentation approval.
  • Drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements.
  • Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
  • Ensure adequate quality reviews (periodic system quality reviews, quarterly utilities monitoring reports)
  • QA follow-up of utilities/Beltech related projects and project management.
  • Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used Pharma & Injectable, T2, T4 and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and Corporate Policies & Procedures

Back up fonction

  • The position can act as back-up for his direct colleagues or for his manager according to the Manager 's instructions and after appropriate training

Your profile:

  • Master's degree in a relevant field (e.g., Engineering, Science or a related discipline).
  • Experience in a regulated pharmaceutical environment or other life science or health related field is mandatory
  • Experience with Quality Management Systems and Auditing is an asset
  • Fluent in French, very good level in English is required
  • Affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices
  • Team player with good interpersonal relationships and communication skills

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]

Launch Excellence Project Engineer

  • Location: PUURS
  • Job #27501

Launch Excellence Project Engineer

Antwerpen – Contracting

Mission:
The Launch Excellence Project Engineering service is responsible for managing validation activities related to the introduction of new products at the manufacturing site.
The role ensures that all processes linked to product launch comply with regulatory requirements, internal quality standards, and GMP guidelines throughout the product lifecycle.
The service also contributes to project coordination, risk management, and quality investigation activities required for successful product implementation.
Key Responsibilities:

  • Validation Activities
  • Plan, execute, and document validation activities associated with new product introduction.
  • Validate processes related to: formulation, filling, shipping, packaging
  • Ensure validation documentation complies with GMP and regulatory standards.
  • Execute and document urgent quality investigations.
  • Analyze deviations, identify root causes, and implement corrective actions.
  • Ensure traceability and documentation of all investigations.
  • Conduct risk assessments for processes and systems.
  • Identify potential risks related to product implementation.
  • Define and implement risk mitigation strategies.
  • Support process changes and system updates related to new product introduction.
  • Collaborate with cross-functional teams to implement improvements.
  • Coordinate project activities related to product launch.
  • Plan timelines, deliverables, and project milestones.
  • Track progress and resolve issues.
  • Provide project status reporting to stakeholders.
  • Prepare technical and validation documentation.
  • Ensure documentation meets regulatory and internal quality requirements.
  • Maintain organized and auditable project records.

Profile:

  • Master’s degree in a scientific discipline
  • Fluency in Dutch & English
  • Validation processes and documentation
  • Risk assessment methodologies
  • Quality investigation and deviation analysis
  • Knowledge of Good Manufacturing Practices (GMP)
  • Project planning and coordination
  • Technical report writing
  • Work may require flexibility for shift work depending on project needs.
  • Collaboration with multiple departments (quality, manufacturing, engineering, regulatory).

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]
 

Senior Validation Project Engineer

  • Location: PUURS
  • Job #27500

Senior Validation Project Engineer
Contracting – Antwerp

Verantwoordelijkheden

  • Coördineren van validatie- en verificatieactiviteiten binnen kapitaalprojecten.
  • Opstellen en beheren van projectplanningen en validatieplannen.
  • Zorgen voor een correcte implementatie van validatiestrategieën tijdens de uitvoering van projecten.
  • Interpreteren en toepassen van GMP-regelgeving (EU en VS), internationale normen (ISO, ICH) en Pfizer Quality Standards (PQS).
  • Garanderen dat alle activiteiten voldoen aan regulatoire en interne kwaliteitsvereisten.
  • Opstellen, beoordelen en goedkeuren van validatiedocumentatie.
  • Zorgen voor traceerbare en conforme documentatie voor audits en inspecties.
  • Fungeren als belangrijk aanspreekpunt tussen Engineering en Quality Assurance voor validatie-, verificatie- en change control processen.
  • Faciliteren en uitvoeren van Quality Risk Assessments (QRA).
  • Expertise leveren op het gebied van validatie, verificatie en Quality Risk Management (QRM).
  • Beheren van één of meerdere producten of engineeringprojecten.
  • Ondersteunen van nieuwe productintroducties.
  • Coördineren van proceswijzigingen en continue verbeteringen.
  • Beheren van dringende kwaliteitsonderzoeken en uitvoeren van risicoanalyses met bijhorende mitigatieacties.
  • Toezien op kwalificatie en validatie van laboratoriummethoden en verbeteringen (indien van toepassing).
  • Ondersteunen bij de ontwikkeling van computer-gestuurde laboratoriumsystemen.
  • Fungeren als back-up voor andere projectingenieurs wanneer nodig.

Profiel

  • Masterdiploma in (bio)ingenieurswetenschappen, industriële farmacie, biochemie, biotechnologie of gelijkwaardig door ervaring.
  • Ervaring in een farmaceutische productieomgeving is een plus.
  • Kennis van GMP-regelgeving (EU/VS) en validatie- en kwalificatieprocessen.
  • Ervaring met Quality Risk Management en projectcoördinatie.
  • Sterke communicatie- en organisatorische vaardigheden.
  • Nauwkeurig, gestructureerd en sterk in technische documentatie.
  • Vloeiend in Nederlands en Engels.

 

CSV Engineer

  • Location: Wavre
  • Job #27499

CSV Engineer

Contracting – Brabant Wallon

Your responsibilities:

  • Writing, reviewing and approving of validation plans and validation summary reports
  • Reviewing and approving of design documentation (TCD, ERES, URS, DQ, …)
  • Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
  • Writing and reviewing of Periodic Review Reports (PR)
  • Reviewing and approving of CSV specific documentation (inventory, …)
  • Reviewing of CVS specific SOP’S and Templates
  • Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerized systems.
  • Ensure QA activities on quality systems (CAPA, Deviation, Change Control, …) related to automated and computerized systems.
  • Support team and management during internal and external audits

Your profile:

  • CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
  • Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …)
  • Quality oriented.
  • University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
  • Certification in computer system validation or equivalent is a plus.
  • Experience in a computer systems validation role
  • Experience with SAP, MS Office
  • 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]