Job Location: PUURS

• Location: /
• Job #27558

Validation Project Engineer
Vast contract – Antwerpen 

Jouw verantwoordelijkheden?

De rol van Project Engineer is een uitdagende job waarbij je veel kennis opbouwt over verschillende productieprocessen en systemen en waarbij je de kans krijgt om de high level wettelijke vereisten te vertalen in een praktisch uitvoerbare en aanvaardbare approach.
Deze functie biedt veel variatie en interactie met verschillende afdelingen zoals productie, engineering, QA, ECO en site compliance.

Als Project Engineer sta je in voor volgende taken:

• Je voert validatieprojecten uit van aanpassingen aan bestaande processen
• Je onderhoudt het media fill systeem en voert vernieuwingen en verbeteringen door
• Je bent aanspreekpunt voor andere afdelingen als expert in de validatie van aseptische vulprocessen

Wie ben je?

• Bij voorkeur heb je een masteropleiding in een wetenschappelijke richting gevolgd
• Je hebt kennis van aseptische productie en affiniteit met productiesystemen
• Je bent sterk in analytisch denken en prioriteiten stellen
• Je kan ordelijk en gestructureerd werken
• Je bent een teamplayer met een positieve attitude
• Kennis van aseptische kwaliteitssystemen is een nice-to-have
• Kennis in project management en microbiologie is een troef
• Perfecte beheersing van het Nederlands en het Engels

Wat kan je verwachten?
Je komt terecht in een internationale en innovatieve werkomgeving waar veiligheid, kwaliteit en samenwerking centraal staan. Je ontvangt een competitief loonpakket en uitgebreide extralegale voordelen, met volop kansen om je technische kennis verder te ontwikkelen en bij te dragen aan uitdagende projecten.

• 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.

• 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).

 

• Location: /
• Job #27437

Project Engineer Medical Devices
Antwerpen – contracting 

Your responsibilities?

• Provide technical, scientific and project-driven support to ensure robust pharmaceutical manufacturing within Site Technical Services (STS) MDCP.
• Lead and/or support technical improvements, problem solving and the execution of implementation projects, fully aligned with GMP and internal quality systems.
• Sustain on-market Medical Device and Combination Products (MDCP) through product/process change and risk management activities as Technical Leader.
• Act as production site and R&D facing role.
• Facilitate product launch.
• Lead post-market changes.
• Identify opportunities for continuous improvement.
• Support investigations of delivery system customer complaints to determine root cause and implement appropriate corrective preventive actions.
• Support Manufacturing Quality Assurance in the disposition of Non-Conforming Reports, qualification of material / processes / changes to assure reliability requirements are met.
• Lead or support project management activities including scoping, planning, risk assessments and execution of improvement or investment projects.
• Drive process and system improvements (lean/continuous improvement) with a focus on Design History File (DHF) enhancements / updates for specific device presentation / platform.
• Prepare, execute and document changes with a focus on design changes, process changes and risk management updates; perform impact assessments and required (re)qualification.
• Develop and maintain technical documentation (protocols, reports, work instructions, risk analyses).
• Coordinate with Operations, QA, Engineering and suppliers; ensure clear communication and on-time delivery.
• Identify, communicate, develop mitigation strategies for technical risks with key stakeholders per appropriate escalation threshold.
• Promote and comply with EHS guidelines; integrate safety requirements in designs and changes.

Your profile?

• Engineering degree (Bio-engineering or Industrial Engineering preferred)
• Project Engineer with experience
• Able to work independently from the start
• Autonomous and practical mindset
• Strong project engineering fundamentals 
• GMP knowledge is a plus

Strong plus (not mandatory):

• Design control
• Medical device regulations
• Product design in MedTech
• Injection techniques related to MedTech
• Risk assessment and control strategy in MedTech

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.

 

• Location: Puurs
• Job #27406

Project Engineer – Pharmaceutical
Antwerpen – contracting 

What are your responsibilities?

• Services involve the interpretation and application of GMP regulations (US, EU), international standards (ISO, ICH), and Pfizer Quality Standards (PQS).
• The service includes coordinating verification/validation activities, drafting and reviewing validation documents, and acting as a primary contact for Engineering and Quality Assurance regarding validation and change control.
• The service involves facilitating Quality Risk Assessments and serving expertise in verification/validation/QRM.
• Furthermore, services extend to managing one or more products or projects, addressing urgent quality investigations, conducting risk assessments, implementing changes, and introducing new products.
• For laboratory contexts, the service is being responsible for qualification and validation of method improvements, developing computer-controlled systems, and providing backup for other project engineers.

Who are you? 

• Master's degree in civil, industrial, bioengineering, industrial pharmacy, or equivalent by experience, or a scientific field (Bio engineer, Pharmacist, Biochemistry, Biotechnology).
• Experience in production environments, pharmaceutical industry, aseptic processes, cleaning, disinfection, and sterilization are advantageous.
• Strong communication, stakeholder management, organizational skills, accuracy, and technical writing abilities are essential.
• Proficiency in Dutch and English is 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.
 

• Location: Puurs
• Job #27405

Launch Excellence Project Engineer
Antwerpen – contracting 

What are your responsibilities?
The Service Description: Launch Excellence Project Engineering entails being responsible for managing validation aspects associated with the introduction of new products into the site.The scope covers a broad range of activities required to ensure successful implementation and regulatory compliance throughout the product lifecycle.

• Validating and documenting support for formulation, filling, shipping, and packaging processes.
• Executing and documenting urgent quality investigations.
• Performing comprehensive risk assessments and defining appropriate mitigation measures.
• Supporting and implementing process and system changes related to product introduction.
• Providing overall project management, including coordination, planning, issue resolution, and progress reporting. 

Who are you? 

• Master's degree in a scientific field such as Bio-engineering, Pharmacy, Biochemistry, or Biotechnology.
• A perfect command of Dutch and good knowledge of English (written and oral) are required.
• Strong communication and interpersonal skills, be team players, and demonstrate an organized, accurate, and quality-conscious work approach.
• Analytical skills, problem-solving abilities, and a good technical writing style are crucial.
• Experience in executing validation projects and proficiency in planning and project coordination are highly valued.
• The project often requires a pragmatic, proactive, and results-focused individual who can take the lead and work both independently and collaboratively.
• Experience in a Good Manufacturing Practices (GMP) environment and familiarity with risk assessment and validation processes are important.
• Flexibility for shift work may be required for certain projects.

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.
 

• Location: /
• Job #27311

Digital Strategy & Program Lead – Connected Factory
Contracting – Antwerp

Job Purpose
Execute the Digital Strategy to deliver one fully digitalized and connected manufacturing facility.
The role is responsible for executing the end-to-end Digital strategy for a new industrial facility, covering the full Digital landscape: from infrastructure foundations to Digital applications and products, and from project delivery through operational mode (post-PPQ batches).
This position ensures that Digital systems are designed, implemented, validated, and operated in full alignment with business objectives, regulatory requirements, and industry best practices.

Role Objectives

• Define and organize the governance required to manage, steer, and report Digital program activities, addressing challenges and issues as they arise
• Report progress and key risks within the program and to the broader Digital organization
• Lead the planning, development, and implementation of all Digital systems required for efficient and compliant factory operations
• Ensure alignment of Digital objectives with overall business, engineering, quality, and operational goals
• Oversee the deployment of appropriate technologies supporting production, automation, and plant management processes
• Ensure full compliance with Digital standards (infrastructure, cybersecurity, validation) across all stakeholders, including Digital, Engineering, Quality, and external partners

Main Responsibilities

• Establish and manage the Digital project schedule, including critical milestones and delivery deadlines, fully aligned with the overall project plan
• Develop and maintain a detailed Digital project plan covering:
  • Infrastructure and hardware acquisition
  • Digital applications and products rollout
  • Transition to routine operational mode for all Digital elements
• Coordinate cross-functional teams to ensure Digital systems are designed and implemented in compliance with regulatory requirements and industry best practices (GxP, SOX, Cybersecurity, etc.)
• Collaborate closely with Engineering teams to ensure automation and equipment systems (e.g. SCADA, DCS/DeltaV, MES) are implemented in strict adherence to Digital guidelines
• Track and manage Digital project costs
• Identify, assess, and mitigate project risks, defining and implementing contingency plans when required
• Provide technical expertise and thought leadership to resolve complex Digital and operational challenges
• Ensure clear, structured, and regular communication with all stakeholders regarding progress, risks, and key decisions

About You
You are experienced in executing multi-year Digital strategies and combine strong technical expertise with excellent leadership and communication skills. You are comfortable operating in complex, regulated, and international environments.
Experience

• Significant experience managing complex Digital programs or projects, preferably in an industrial or pharmaceutical environment
• Proven project management expertise, including leadership of technical and functional teams
• Experience working in international and remote team contexts

Skills & Competencies

• Strong leadership and stakeholder management capabilities
• Excellent communication, facilitation, and negotiation skills
• Solid understanding of Digital systems, infrastructure, and industrial IT/OT landscapes
• Ability to operate across strategic, tactical, and operational levels

Languages

• Fluent in English
• Flemish or French is a strong plus

 

• Location: /
• Job #27294

Validation Engineer CSV
Contracting – Antwerp

Verantwoordelijkheden

• Ontwikkelen, implementeren en uitvoeren van URS-, SIA-, DQ-, IQ-, OQ-, PQ-, RV- en TM-activiteiten.
• Ontwikkelen, implementeren en uitvoeren van validatiestudies voor cGMP-kritische gecomputeriseerde systemen om naleving van cGMP-, gebruikers- en regelgevingseisen aan te tonen. Dit betreft een hands-on rol.
• Opstellen van validatiedocumentatie (protocollen en rapporten) en ondersteuning bieden bij de uitvoering van validatieprotocollen voor gecomputeriseerde systemen.
• Verantwoordelijk voor validatiedocumentatie tot en met goedkeuring en implementatie.
• Uitvoeren van systeemvalidatie waarvoor industriële precedenten bestaan, maar waarbij interpretatie van standaarden nodig is, in overeenstemming met cGMP, cGLP en Sanofi-procedures.
• Waarborgen dat de gevalideerde status van gecomputeriseerde systemen te allen tijde voldoet aan cGMP-vereisten.
• Zorgen dat projecten worden beheerd volgens alle vereiste Sanofi-standaarden en cGMP-regelgeving.
• Op de hoogte blijven van nieuwe validatieregelgeving en testpraktijken om te blijven voldoen aan of te overtreffen aan cGMP-vereisten. Bieden van technische ondersteuning met betrekking tot actuele FDA- (VS) en EU-validatievereisten.
• Bijdragen aan de beoordeling van wijzigingen en inschatten of deze impact hebben op de gevalideerde status en bijbehorende validatiedocumentatie.
• Onderzoeken en oplossen van validatie-issues en afwijkingen.

Wij zijn op zoek naar een Validation Engineer met projectervaring in de validatie van softwarepakketten en gecomputeriseerde systemen.

Vaardigheden en ervaring

• Sterke communicatieve vaardigheden
• In staat om zelfstandig te werken en snel nieuwe kennis op te nemen
• In staat om projecten volgens planning uit te voeren
• Grondige kennis van Computer Systems Validation (CSV)
• Volledig begrip van relevante kwaliteits- en compliance-regelgeving
• Vaardig in het analyseren en oplossen van validatieproblemen
• Minimaal 3 jaar ervaring in de farmaceutische sector en een GMP-omgeving
• Goede kennis van zowel Engels als Nederlands
• Ervaring met DCS-systemen (Emerson DeltaV) is een pluspunt

 

• Location: /
• Job #27293

Project Engineer HVAC
Contracting – Antwerp

Functieomschrijving
Als Project Engineer HVAC ben je verantwoordelijk voor de technische opvolging en uitvoering van HVAC-projecten binnen een gereguleerde farmaceutische productieomgeving. De focus ligt op ventilatie, cleanroominstallaties en commissioning-activiteiten. Je werkt hands-on mee in de constructieve fase van het project en fungeert als technisch aanspreekpunt tussen verschillende interne departementen en externe partijen.

Taken en verantwoordelijkheden

• Nakijken en beoordelen van technische fiches en documentatie
• Actieve betrokkenheid in de constructie- en commissioningfase van HVAC-installaties
• Inregelen van luchtkleppen en opvolgen van ventilatieprestaties
• Coördineren en opvolgen van installatie, opstart en verificatie van HVAC-systemen
• Hands-on ondersteuning op de werf en in productieomgevingen
• Communiceren en samenwerken met diverse afdelingen (Engineering, QA, Operations, Contractors)
• Sporadisch opstellen en/of aanvullen van technische en validatiedocumentatie
• Werken volgens geldende GMP-, veiligheids- en kwaliteitsrichtlijnen
• Meewerken aan risicoanalyses en continue verbeteringen

Profiel

• Ingenieursdiploma (Industrieel, Burgerlijk of gelijkwaardig door ervaring)
  • Indien geen specifieke HVAC-opleiding: ingenieursachtergrond is een must
• Medior tot senior ervaring in HVAC of technische projectengineering
• Sterke hands-on mentaliteit en proactieve werkhouding
• Goede kennis van ventilatietechnieken
  • Kennis van F-gassen is een sterke meerwaarde
• Ervaring in een gereguleerde omgeving (bij voorkeur farmaceutisch, GMP)
• Sterke communicatieve vaardigheden en vlot in samenwerking met verschillende stakeholders
• Zelfstandig kunnen werken, maar ook teamgericht
• Goede organisatorische vaardigheden en het vermogen om prioriteiten te stellen

Talen

• Nederlands: zeer goed
• Engels: zeer goed

Extra troeven

• Ervaring met commissioning van HVAC-installaties
• Kennis van GMP, risicomanagement (bv. FMEA)
• Ervaring met CAPEX-projecten en projectcoördinatie

 

• Location: PUURS
• Job #27290

Laboratory Operations Project Engineer
Antwerp – Contracting
Our partner is looking for a Lab Operations Project Engineer to join its team. This international company is well known for its pharmaceuticals.
Lab Operations Project Engineering entails being responsible for the compliance assessment of method validation and compendial compliance dossiers. This service involves the careful implementation of new test methods and procedures in Quality Control Operations, including coordinating and planning project activities. 

What are your responsibilities?            

• Implementation of new test methods and procedures in Quality Control Operations
• Coordination and planning of project activities
• Writing and reviewing protocols, testing scripts, and reports
• Management of deviations
• Review of validation and transfer test results
• Validation of necessary files (e.g., SoftMaxPro, Excel)
• Verification of compendial tests
• Support of QC analysts during test execution
• Troubleshooting for issues encountered during testing
• Performing root cause analysis using methods such as DMAIC
• Co-authoring submissions for new medicines/vaccines
• Efficient and thorough investigation of analytical deviations
• Determination of root causes and initiation of corrective and preventive actions to address quality-related deficiencies
• Execution of strategic initiatives
• Resolution of complex issues
• Development of innovative solutions
• Guidance of technical direction
• Coordination of other resources and facilitation of knowledge transfer within service parameters

Who are you?

• Master’s degree is commonly required, typically in industrial, civil, or bio-engineering, or industrial pharmacy, or a scientific field such as biochemistry or biotechnology
• Perfect command of Dutch and good knowledge of English (written and oral) is required
• Strong communication skills (written and oral)
• Strong organizational skills and accuracy
• Strong technical writing ability
• Analytical skills and problem-solving abilities
• Experience in a GMP environment is required
• Team player with strong interpersonal skills

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.