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.
Quality Project Associate Antwerp – Contracting Our partner is looking for a Quality Project Associate to join its team. This international company is well known for its pharmaceuticals. What are your responsibilities? The Quality Project Associating services focus on quality oversight and project support, delivering essential quality oversight and comprehensive project support for pharmaceutical processes and products within the company Belgian sites, specifically the aseptic manufacturing plant. Provide technical, operational, compliance, and qualification support for GMP and non-GMP systems
Provide quality oversight and comprehensive project support for pharmaceutical processes and products
Act as an independent quality authority for product-related qualifications and validations
Ensure regulatory CMC compliance of plant processes with regulatory filings
Contribute to compliant and right first-time product launches
Perform quality reviews of validation documentation, change records, and procedures
Coordinate regulatory submissions
Support Quality Management Systems, including validation, Quality Risk Management (QRM), and change management
Conduct end-to-end validations of new products (formulation, filling, and packaging)
Prepare validation documentation
Monitor production batches
Analyze validation results
Perform root cause investigations for deviations and propose corrective and preventive actions
Support the creation and maintenance of Master Batch Records
Actively contribute to continuous improvement initiatives
Who are you?
Master’s degree in a relevant scientific or engineering discipline (Industrial Engineering, Civil Engineering, Bio-engineering, (Industrial) Pharmacy) or equivalent experience in Biochemistry or Biotechnology
Know-how of project management within the pharmaceutical or related industries
Strong experience in GMP-regulated and aseptic environments
Strong analytical and problem-solving skills
Excellent organizational skills
Meticulous, accurate, and quality-conscious work approach
Strong communication, interpersonal, and technical writing skills
Ability to collaborate effectively with cross-functional teams and external stakeholders
Perfect command of Dutch and good knowledge of English (written and oral)
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.
Process Engineer Antwerp – Contracting Our partner is looking for a Process Engineer to join its team. This international company is well known for its pharmaceuticals. What are your responsibilities? Process Engineering entails being responsible for technical, operational, compliance, and qualification support for GMP and non-GMP systems within the company’s manufacturing and R&D environments. This encompasses project management and execution of discrete work scopes for overall project delivery, with a strong focus on process design, equipment validation, and continuous improvement.
Provide technical, operational, compliance, and qualification support for GMP and non-GMP systems
Manage and execute discrete project work scopes to support overall project delivery
Support process design, equipment validation, and continuous improvement initiatives
Identify and resolve production bottlenecks
Conduct root cause investigations for quality deviations
Implement changes to existing equipment
Support the introduction and validation of new products and processes
Develop and implement automated visual inspection systems
Manage and support electronic batch records
Support tech transfer activities for vaccine manufacturing processes
Provide support for product validation activities, including follow-up and support of launch projects
Document qualification work in aseptic manufacturing and engineering
Support routine operations in line with established procedures
Who are you?
Master’s degree in industrial, civil, bio-engineering, chemical, or mechanical engineering, or an industrial pharmacist degree
Experience in an engineering, technical, or operations role within a GMP industrial environment
Proven expertise in projects and equipment qualification
Strong analytical and problem-solving skills with a structured approach
Ability to work independently and as part of a team
Excellent written and verbal communication and interpersonal skills
Proficiency in Dutch and English
Experience with process equipment
Knowledge of structured problem-solving methodologies (e.g., FMEA)
Experience with control systems (PLC, SCADA)
Flexibility for shift work or weekend coverage may be required for some projects
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.
Kwalificeren en valideren van analytische methoden en method improvements
Opstellen en uitvoeren van validatie- en kwalificatieprotocollen
Coördineren van laboratoriumactiviteiten en opvolgen van analyses
Interpreteren van resultaten en opstellen van technische rapporten
Faciliteren en uitvoeren van risicoanalyses (Risk Assessments)
Ondersteunen van verificatie- en validatieactiviteiten
Beheren van één of meerdere projecten, inclusief planning en opvolging
Onderzoeken en oplossen van dringende kwaliteitsissues
Implementeren van wijzigingen en introduceren van nieuwe methoden en apparatuur
Ontwikkelen en kwalificeren van computer-gestuurde systemen voor laboratoriumtoepassingen
Fungeren als back-up en kennisdrager voor andere project engineers
De functie vereist het correct interpreteren en toepassen van: GMP-regelgeving (EU, US, …), Internationale richtlijnen en standaarden (zoals ISO, ICH), Interne kwaliteitsstandaarden en procedures
Profiel en kwalificaties
Masterdiploma in industriële wetenschappen, bio-ingenieurswetenschappen, industriële farmacie of gelijkwaardig door ervaring
Of een wetenschappelijke opleiding zoals Bio-ingenieur, Farmaceut, Biochemie of Biotechnologie
Ervaring in een farmaceutische (GMP) laboratorium- of productieomgeving is een sterke troef
Praktische ervaring met method validatie, validatiestrategieën en statistische data-analyse
Sterke analytische vaardigheden en oog voor detail
Uitstekende communicatieve en organisatorische vaardigheden
Ervaring met stakeholdermanagement en technische documentatie
