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.
Ben jij een gedreven .NET developer die graag werkt aan slimme webtoepassingen, krachtige integraties en maatwerksoftware die het verschil maakt? Bij dit innovatieve IT‑bedrijf werk je mee aan bedrijfskritische en cyberveilige software voor grote organisaties, in een team van enthousiaste en ervaren collega’s.
Wat ga je doen
Meedenken en adviseren in de analysefase met diverse stakeholders
Technische analyse en samenwerking met analisten om haalbare oplossingen uit te werken
Ontwikkelen en testen in een agile omgeving (sprints van 3 weken) met regelmatige feedback naar de klant
Integreren van beste beveiligingspraktijken (OWASP, DevSecOps) in elke fase
Deelname aan sprint planning, retrospectives, daily stand-ups en demo’s
Mogelijkheid om door te groeien naar technisch team lead en collega’s te coachen
Zorgen voor kwaliteit en gebruiksvriendelijkheid, zodat klanten enthousiast zijn bij demos
Profiel
Minimaal 3 jaar ervaring met softwareontwikkeling in .NET / .NET Core
Passie voor software engineering en kwalitatieve code
Hands-on mentaliteit en bereid verantwoordelijkheid te nemen
Kan complexe vraagstukken eenvoudig vertalen voor eindgebruikers
Ambitie voor continue groei en innovatie, zelfstandig werken én in teamverband
Technologie & tools
.NET / .NET Core, C#
REST API’s, SQL Server, PostgreSQL
Cloudplatforms zoals Azure of AWS, Terraform
CI/CD pipelines, SSDLC, agile/Scrum-methodieken
Wat wij bieden
#RemoteFirst: bepaal zelf waar je werkt, met flexibele werk-privébalans
Op maat verloningspakket op basis van ervaring en competenties
Impactvolle projecten waar jouw inzet zichtbaar resultaat levert
Warm, mensgericht team en cultuur waarin je je snel thuis voelt
On-the-job learning en kennisdeling met ervaren collega’s
Startdatum: in overleg, afgestemd op jouw beschikbaarheid
Ben jij een gedreven software engineer die graag werkt aan bedrijfskritische en cyberveilige enterprise software? Bij ons werk je mee aan maatwerkprojecten voor grote organisaties, waarbij jouw werk écht het verschil maakt.
Wat ga je doen?
Meedenken en adviseren tijdens de analysefase met diverse stakeholders
Samenwerken met analisten en technische teams om haalbare oplossingen uit te werken
Ontwikkelen en testen in een agile omgeving met regelmatige feedback naar de klant
Integreren van beste beveiligingspraktijken (OWASP, DevSecOps) in elke fase van de ontwikkeling
Actief deelnemen aan sprint planning, retrospectives, daily stand-ups en demo’s
Mogelijkheid om door te groeien naar technisch team lead
Ondersteunen en coachen van collega’s, met oog voor kwaliteit en eindgebruikerservaring
Profiel
Minimaal 3 jaar ervaring in softwareontwikkeling, bij voorkeur met .NET en Angular
Passie voor software engineering en kwalitatieve code
Hands-on mentaliteit en verantwoordelijkheid nemen
Complexe vraagstukken kunnen vertalen naar gebruiksvriendelijke oplossingen
Kritische blik en focus op detail
Ambitie voor continue groei en innovatie
Technische omgeving
.NET / .NET Core, C#
Angular, Typescript, JavaScript, HTML, CSS
REST API’s, SQL Server, PostgreSQL
Cloud: Azure of AWS
CI/CD pipelines, SSDLC, Terraform
Agile/Scrum-methodieken
Wat wij bieden
Remote-first werkmodel: bepaal zelf waar je werkt
Flexibele werk-privébalans: combineer werk met gezin, hobby’s en afspraken
Op maat samengesteld verloningspakket op basis van jouw kennis, ervaring en verwachtingen
Impactvolle projecten: jouw inzet maakt echt het verschil bij onze klanten
Samen groeien: dagelijkse kennisdeling, on-the-job-learning en samenwerking met experts
Warm team & cultuur: je voelt je snel thuis in een mensgerichte en positieve werkomgeving
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
