Wij zijn op zoek naar technisch operatoren die aan de slag willen in een 3‑ploegensysteem (06u–14u, 14u–22u, 22u–06u). Van maandag t.e.m. vrijdag, geen weekendwerk.
Als technisch operator werk je op een afdeling waar productielijnen draaien voor de vervaardiging van hoogwaardige producten. Samen met je collega‑operatoren draag je de volledige technische verantwoordelijkheid over de lijn en zorg je voor een efficiënt, veilig en kwalitatief productieproces.
Jouw takenpakket
Opstarten en stilleggen van de productielijn volgens vastgelegde procedures
Aanvoeren van grondstoffen en materialen
Uitvoeren van regelmatige technische en kwaliteitscontroles
Oplossen van technische storingen aan machines en installaties
Uitvoeren van preventief onderhoud (smeren, controle, kleine aanpassingen)
Registreren van alle procesgegevens in een logboek
Wie ben jij?
Ervaring als technisch operator of in een vergelijkbare technische functie
Indien je al in het bezit bent van een heftruck, reachtruck of stapelaar attest, is dit mooi meegenomen
Je werkt graag zelfstandig en neemt verantwoordelijkheid
Fysiek werk schrikt jou niet af
Je beheerst het Nederlands (spreken, lezen en schrijven)
Marktconform loon, verhoogd bij relevante ervaring
Ploegenpremie, nachtpremie en kilometervergoeding
Wie zijn wij? Bij Manpower Talent Based Outsourcing (TBO) bieden we outsourcing- en contracting-opportuniteiten bij allerlei internationale en nationale bedrijven. Als onze associate werk je op een project bij een van onze klanten. Deze projecten zijn van korte (minstens 3 maanden) tot zeer lange (meerdere jaren) duur. We specialiseren ons in de domeinen: Administration, Healthcare Support, Logistics & Automotive, Sales & Marketing.
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.
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.
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.
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
Qualification and Validation Engineer Antwerpen – Contracting Our partner is looking for an Qualification & Validation Engineer to join its team. This international company is well known for its pharmaceuticals. What are your responsibilities?
Develops, implements and executes URS, CAT, SIA, DQ, IQ, OQ, PQ, RV and TM activities for small scale equipment in QC and Manufacturing, including the related software. Develops, implements and executes validation studies for cGMP-critical process systems to demonstrate compliance with cGMP, user and regulatory requirements. This role involves hands-on activities.
Performs qualification of systems in scope where industry precedence exists, but where standards require case-specific interpretation. Ensures all activities are in accordance with cGMP, cGLP and Sanofi Procedures.
Ensures that the qualified status of systems in scope is in compliance with cGMP at all times.
Supports projects in conjunction with all required Sanofi and cGMP regulatory standards.
Maintains current knowledge on emerging validation regulations and validation testing practices in order to meet or exceed cGMP requirements. Provides technical assistance on current US FDA and EU validation requirements.
Takes responsibility for the validation documentation through approval and implementation.
Provides input in the review and assessment of changes to assess whether they impact the qualified status and validation documentation, as appropriate.
Who are you?
Knowledge of cGMP requirements in a regulated environment.
Understanding of relevant quality and compliance regulations.
Ability to troubleshoot validation issues.
Good knowledge of quality management systems.
Experience: 2-4 years working in a healthcare manufacturing environment, with experience in qualification of small scale equipment (including the related software).
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.
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
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
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.
Jouw verantwoordelijkheden? De Batch Doc reviewer is verantwoordelijk voor het kwalitatief, nauwkeurig,efficiënt, volgens instructies en binnen de correcte aflevertijd nakijken van batchdocumentatie voor klinische studiemedicatie.
• Als batch doc reviewer in de verpakkingsafdeling zal je ingezet wordenin dagshift. • Je kijkt na dat alle interventies en handelingen, uitgevoerd door operatoren zijngedocumenteerd in de batch documenten. Hierna worden deze batchdocumenten ter review aangeboden aan QA. • Indien nodig, zal je mee ingezet worden om eventuele afwijkingen teonderzoeken, opvolgen en te documenteren in het Trackwise systeem. • Je helpt mee met de klachtenbehandeling van interne en externe partijen. • Alle activiteiten dienen volgens SOP en GMP richtlijnen uitgevoerd te worden.
Wie ben je? • Kennis van cGMP • In staat om praktijkgericht te denken in kader van kwaliteit & veiligheid. • Flexibel met een gevoel van urgentie. • Een goede team player met gepaste communicatie en in staat om metverschillende profielen en afdelingen samen te werken (e.g.planning, QA, batchdoc&label group, teamleads, operators,engineering and technical services.) • Bij voorkeur heb je ervaring met klinische verpakking en structuren • Zeer grondige kennis van GMP en goede documentatie richtlijnen • Professionele kennis inzake veiligheid, hygiëne en milieureglementeringen • Je bent gebonden aan vastgelegde processen en procedures • Je doet beroep op de leidinggevende bij escalatie van problemen
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.
