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.
Production Engineer Aseptic Support Contracting – Antwerp
De afdeling Aseptic Systems vormt de brug tussen Quality Assurance (QA) en Productie. De afdeling is verantwoordelijk voor het beheer, de optimalisatie en de ondersteuning van volgende aseptische systemen:
Glove Management
Aseptische- en Isolator Technieken
Gowning
Materiaaltransfer
Cleaning & Desinfectie
Als Production Engineer Aseptic Support ondersteun je productieafdelingen door kwaliteitsvolle, GMP-conforme en praktisch toepasbare oplossingen te ontwikkelen. Je werkt nauw samen met productie-operatoren, supervisors en QA en speelt een sleutelrol in het verbeteren van aseptisch werken. Deze functie biedt de ideale balans tussen kwaliteit, engineering en productie.
Takenpakket en verantwoordelijkheden Operationele ondersteuning & expertise
Fungeren als aanspreekpunt voor aseptische systemen binnen een toegewezen productieafdeling
Optreden als inhoudelijk expert in aseptische systemen en advies verlenen bij wijzigingen en projecten (GMP, compliance en praktische uitvoering)
Ondersteunen bij problem solving rond nieuwe of gewijzigde aseptische handelingen
Ontwikkelen en optimaliseren van operatorhandelingen bij nieuwe vullijnen
Projecten & verbeteringen
Leiden en ondersteunen van verbeterprojecten gericht op kwaliteit, compliance en kostenefficiëntie
Bijdragen aan site-wide projecten door impactanalyses uit te voeren en implementaties te ondersteunen
Uitvoeren en documenteren van Quality Risk Assessments
Samenwerking & communicatie
Organiseren en leiden van multidisciplinaire meetings met productie (operatoren, supervisors, QA)
Actieve samenwerking met QA en Productie om aseptisch werken continu te verbeteren
Fungeren als verbindende schakel tussen kwaliteitsvereisten en operationele realiteit
Validatie, training & coaching
Ondersteunen bij validatieactiviteiten
Ontwikkelen en geven van trainingen aan operatoren
Coachen en begeleiden van operatoren bij de implementatie van wijzigingen en nieuwe werkwijzen
Profiel Opleiding & ervaring
Bij voorkeur een masteropleiding in een wetenschappelijke richting
Ervaring met of sterke affiniteit voor aseptische productie en productiesystemen
Kennis van aseptische kwaliteitssystemen is een plus
Kennis van project management en/of microbiologie is een troef
Competenties
Sterk analytisch denkvermogen en in staat prioriteiten te stellen
Ordelijk, gestructureerd en nauwkeurig
Teamplayer met een positieve en proactieve attitude
Communicatief sterk en overtuigend, kan omgaan met diverse persoonlijkheden
Beschikt over coaching- en trainingsvaardigheden
Flexibel en bereid om regelmatig vroege, late of nachtshifts te doen
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27302
Vendor Quality Lead
Contracting – Brabant Wallon
Your responsibilities: We are looking for a Vendor Quality Lead to reinforce the R&D & Pharmacovigilance Vendor Quality team. The role is needed to support GCP-focused vendor qualification activities, quality agreements setup, and vendor oversight, especially due to a current backlog of agreements and increasing number of GCP vendors.
Managing GCP vendor qualification activities.
Handling the setup, review, update and closure of Quality Agreements (priority scope).
Proven experience in vendor qualification / vendor management.
Solid experience in Quality Agreements lifecycle management.
Knowledge of regulatory requirements (EMA/FDA/ICH).
Experience with risk‑based oversight and CAPA lifecycle.
Fluent English & French.
Ability to work with digital tools and comfortable with technological processes.
Strong professional judgment, ability to act independently and manage complex situations.
Nice to have
Experience with Digital/IT systems, data integrity, IT validation, eClinical tools.
Legal/paralegal background is an asset for Quality Agreement work.
Experience with AI‑driven or digitalization initiatives.
Vendor management experience in additional GxP areas (but not GMP/GDP profiles).
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]
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
Project Validation Coordinator Antwerp – Contracting Our partner is looking for a Project Validation Coordinator to join its team. This international company is well known for its pharmaceuticals. The Project Validation Coordinator (VALCO) supports the project lead in coordinating the project team to achieve defined project deliverables related to validation, as well as the overall project timeline. What are your responsibilities?
Composes and consolidates the overall validation project plan/report and clarifies the validation strategy to the project team, management and inspectors.
Continuously follows up the predefined validation strategy, adjusts and/or escalates if needed and provides overview of the status and potential impact on project timeline.
Coaches the project engineers related to validation and quality systems and watches over good validation practices and the quality of the different deliverables.
Facilitates and documents quality system risk assessment activities.
Provides input for management communication & reporting.
Bridges between Engineering, Quality Projects, STS/LA, SME’s and System Owners.
Functions as subteamlead Validation within the project team charter
Supports the project lead in coordinating the project team to achieve the defined project time line.
Composes, consolidates and maintains the general project schedule file to keep the overview of all milestones towards the completion of the project
Monitors continuously this overall project schedule file and keeps the project team informed regarding the progress and alerts problems/conflicts relating to the execution of project tasks and interrelations of project activities
Assists the project lead to define and evaluate planning risks and mitigation plan.
Provides input for management communication & reporting.
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
Experience in a GMP environment is consistently desired or required
Background in project coordination, validation, and quality systems.
Experience working in cross-functional project teams.
Strong organizational and planning skills.
Ability to coordinate multiple stakeholders and bridge between technical and quality functions.
Good communication skills for interaction with project teams, management, and inspectors.
Proactive, structured, and able to follow up on strategy, planning, and risks.
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.
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.
Ability to handle pushback, challenge stakeholders, and defend QA standards with solid arguments.
Excellent communication & coordination skills.
Ability to work autonomously, analyze data, and make decisions.
Good comprehension of regulatory/CMC requirements.
Nice to have:
Experience in Data Integrity (mindset more important than hands‑on reporting).
Experience in GMP audits & inspections.
Project management skills.
Background in production/manufacturing to better understand operational partners.
Knowledge of biologics + small molecules (products can be pharma or bio).
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]
Location:Braine-l'Alleud, Région wallonne, Belgique
Job#27277
ELN Business Analyst & Developer
Contracting – Brabant Wallon
Your responsibilities:
Business Analysis: conduct stakeholder interviews, process mapping, and current state assessments across CMC Dev laboratories to translate & align needs into clear requirements or user stories, and testing scripts / criteria.
ELN template Design & Development: Apply established processes & style guide to design and configure ELN experiment templates, forms, calculation sheets, workflows, approval steps, audit trails, etc.
ELN structured data structuration: Configure data mapping according to CMC data models ensuring data/metadata schemas are aligned to FAIR principles and scientific and industry domain standards
Optimize usability and search/discovery/re-usability (naming conventions, taxonomies, tagging, template reuse, Inventory), & integration with other computerized systems
Ensure fit for purpose of Digital Operations solutions, and solution & business readiness for implementation – further support change management by monitoring the adoption and performance of newly implemented solutions
Deliver process and solutions documentation, datasets and trainings
Contribute to solutions lifecycle with change requests, impact assessment and continuous improvement
Your profile:
Hands-on expertise configuring and developing within IDBS E‑WorkBook (on premise or Cloud) or similar ELN solution
Hand-on experience and strong understanding of CMC Development laboratory workflows (small molecules, biologics, analytical development, sample & inventory management)
Business Analysis & Product Skills with demonstrated proactiveness, curiosity, analytical and self-reliant mindset
Knowledge of regulatory requirements and quality standards in the biopharmaceutical industry is a plus
Excellent communication, interpersonal and facilitation skills
Continuous improvement and customer-centric thinking, but balanced with an ability to challenge legacy landscape
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]
