Project Engineering for Site Tech Services – Pharmaceutical Vast contract – Antwerpen
Jouw verantwoordelijkheden?
Je behartigt hierbij een breed spectrum van taken waaronder het valideren/implementeren van wijzigingen, het onderzoeken en oplossen van kwaliteitsproblemen en het monitoren van de productkwaliteit om proactief in te grijpen.
Je coördineert, genereert of evalueert nieuwe ideeën, voert haalbaarheidsstudies uit en risk assessments (Cause & effect, FMEA, …), staat in voor validaties en begeleidt mee implementaties in productie.
Je bepaalt de Critical Quality Attributes (kwaliteitsvereisten) van de producten vanuit proces-, product- en wetenschappelijke kennis, en geeft support voor specificaties en wijzigingen van grondstoffen met het oog op productkwaliteit en patient safety en volgens de cGMP regels.
Je profileert jezelf als specialist terzake door continu op de hoogte te blijven van de productie issues en feedback van de markt.
Je analyseert deze info en gebruikt de nodige tools (6 sigma (Green/Black Belt), DMAIC, …) om verbeteringen te realiseren.
Troubleshooting is een belangrijk onderdeel van je job.
Je werkt nauw samen met de leveranciers/productie om bij problemen de juiste acties te implementeren.
Je zorgt ervoor dat steeds gewerkt wordt in compliance met de geldende wetgeving.
Wie ben je?
Master opleiding: Bio-Ingenieur, Industrie-Apotheker, Burgerlijk of industrieel Ingenieur, master of PhD in een wetenschappelijke richting.
+1 j relevante ervaring in farmaceutische omgeving
Enthousiaste teamplayer met de nodige communicatieve vaardigheden
Dynamisch, enthousiast en continue leergierigheid.
Respect voor afgesproken beslissingen en procedures alsook discipline in het uitvoeren van de projecten.
Goede analytische vaardigheden en een kritische mindset.
Perfecte beheersing van het Nederlands en het Engels
Je werkt georganiseerd en accuraat
Nice to have
Expertise in validatie en procesoptimalisatie is een sterke meerwaarde
Project management kennis
Onderzoeksmethodologieën voor root cause onderzoek ikv trouble shooting
GMP omgeving en kennis van kwaliteitssystemen (cGMP)
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.
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.
QA Compliance Support Brabant Wallon – Contracting
Vos responsabilités ? Supporter les activités de production (Filling et Inspection Visuelle) en assurant :
Le suivi, la gestion et la rédaction des déviations, investigations et CAPA's associées
Le suivi des Change Control
Le suivi de projets internes de modification ou d'amélioration.
Supporter les team leader de production dans la gestion des incidents survenant durant les activités de remplissage et d'inspection visuelle pour délivrer un produit injectable de qualité tout en respectant les régies de sécurité et les objectifs du département en termes de cout /délai.
Supporter la production dans le cadre de projets pluridisciplinaires.
Participer activement à définir les stratégies de validation en collaboration avec les équipes validation et en respectant les requis internes
Revoir et approuver l’ensemble de la documentation liée à la validation, y compris les Periodic Review (si nécessaire)
Qualité :
Suivre, gérer et rédiger les déviations et investigations ainsi que les CAPA en collaboration directe avec les team leader, chefs d’équipes, opérateurs, QA et autres services concernés
Supporter les opérateurs, chefs d’équipes et team leaders de production dans la gestion des incidents survenant durant les activités de remplissage et d’inspection visuelle
Effectuer le suivi dans le système de gestion des déviations afin de respecter les délais de traitement des déviations et de libération des lots
Supporter les team leader dans la rédaction, le suivi et l’implémentation des change control relatifs aux activités de production
Respecter et promouvoir la culture qualité interne
S'assurer de l'alignement entre les équipes support et QA et les résoudre le cas échéant
Compliance :
Former et accompagner les équipes de production aux modifications/améliorations apportées aux process dans le cadre des investigations/CAPA/projets
Participer au développement et au maintien du système de qualité en vigueur au sein de la zone de production : supporter le département dans la rédaction des procédures, instructions et formulaires
Support au Département Compliance dans la gestion des change control compliance
Supporter le département à être “permanent inspection readiness”
Revoir la documentation liée à des CAPAs
Amélioration continue : Supporter les initiatives d’amélioration sur le terrain (5S, projets, smarter ways)
Votre profil?
Maitrise des cGMP’s et expérience dans un environnement de production pharmaceutique
Esprit d’analyse
Capacités rédactionnelles de rapports, investigations, procédures
Bonnes aptitudes de communication
Problem solving
Orienté(-e) terrain
Maitrise de l'anglais à l'écrit et à l'oral
Agir en tant que coach pour les autres membres de l'équipe et/ou expert dans certains domaines
Notre offre ? Nous vous offrons un contrat à durée indéterminée ainsi qu'un package salarial attractif. Vous profiterez également de l'opportunité de vous développer personnellement et professionnellement à travers des formations internes. Intéressé(e) ? N'attendez plus !
QA Scheduler Walloon Brabant – contracting Our partner is looking for a QA Scheduler to join its team. Our partner is well known for its pharmaceutical.
The QA Scheduler will design, own and optimize the QA scheduling to enable on-time product release, stable supply, and predictable performance coordinating priorities, risk and capacity. The QA Scheduler will support the designing phase of the role and required digital solutions strongly partnering with QA, Supply Chain and Production. In practice the QA Scheduler will support determining activities lead times, ability of the various Quality departments to abide by supply scheduling according to those defined lead times, review progress against schedule following on potential issues and delays, enabling prioritization and enhancing capacity planning.
Your responsibilities? Design and Deliver QA scheduling model:
Support creation and validation of the future-state QA scheduling model, including prioritization rules, decision logic, roles, and supporting governance
Support design and delivery of the QA digital solution, including MVP development, ensuring alignment to QA master data and end user requirements
Drive day-to-day execution of the design phase to deliver agreed milestones across solution design, governance, and change readiness
Prepare QA and adjacent teams for adoption through training, role clarity, and change management
Own and optimize the QA scheduling:
Translate release plans into a clear, executable QA schedule reflecting batch priority, urgency, and business risk
Maintain and optimize the QA schedule using agreed planning principles, ensuring focus on the most critical batches
Identify and manage short-term capacity constraints and delivery risks, driving timely resolution with leadership and cross-functional partners
Support long-term QA capacity planning by provide insights on demand trends
Enable and drive consistent use of QA digital solutions to improve visibility, prioritization, and decision-making
Identify and lead improvement initiatives to strengthen QA reliability, resilience, and speed
Communicate to stakeholders Deadlines for finalizing deviation investigations, change control action items and document updates in line with the release planning.
Follow up with stakeholder on timely closure of above items to ensure release within committed timelines
Communicate any issues with an impact on the release lead times to supply chain and agree with all involved stakeholders on new deadlines to resolve the issues.
Your profile?
Master’s degree in sciences Pharmacist / master’s in sciences / Bio Engineer pharmaceutical
Understanding of Global pharmaceutical industry including the interpretation and practical application of applicable regulations.
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations.
Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally.
Must possess excellent coordination and team motivation skills.
Must have the ability to independently analyze data and information to draw conclusions and make effective decisions.
Must have ability to identify risks and propose corrective actions within areas of expertise. Also demonstrates initiative and the ability to help others solve problems in a creative and practical way.
Must be dynamic, assertive with strong organizational skills.
Previous experience in change management would be an advantage
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.
R&D and PV Compliance Lead Brabant Wallon – Contracting
Our partner is looking for an R&D and PV Compliance Lead to join its team. This international company is well known for its pharmaceuticals.
What are your responsibilities?
Manage GCP/GLP deviations and CAPA process according to RDPV Quality End-to-End Deviation Management process:
Identify quality issues that would classify as deviation events and facilitate the deviation investigation and root-cause analysis.
Enter and Manage Deviations and CAPA as per Source Quality (Veeva System) Deviation management processes.
Assess proposed CAPA of vendors and liaise with Process Owners, Subject matter experts (Quality or business) to ensure robust CAPAs are developed and negotiate the major observations with vendors or the company business partners.
Manage, track and facilitate the project management of timely review, evidence evaluation and closure of deviations and associate CAPA’s from deviations, audits and inspections.
Follow-up with CAPA owners to ensure timely review, approval and closure from deviations, audits and inspections.
Support development of Effectiveness Checks and ensure timely approval.
Escalate issues early within the company and ensure effective risk-based resolutions are in place.
Monitor the performance of (quality) systems and solutions and the quality of data to support oversight on critical to quality indicators and key decisions.
Conduct analytics and qualitative assessments to identify trends and deliver insights.
Develop periodic KPI and reporting to senior management (compliance dashboard).
Monitor the quality performance of internal processes, strategic vendors and partners.
Maximize the application of AI and machine learning (ML) in deviation management
Who are you?
Bachelor's Degree required; Master's Degree preferred in Life Sciences Related Field.
Preferable 5 years of experience working in the (bio)pharmaceutical industry preferred, with a minimum of 3 years in the research, clinical development or Pharmacovigilance domain.
Experience with managing non-compliance issues in Quality Management system as per deviation management processes. Familiarity with Veeva QMS system is an asset.
Proficient in GCP regulations and applicable regulatory framework. Expertise in another GxP area (GLP/GVP) is an asset.
Ability to translate regulatory and quality expectations into operations, based on knowledge of quality principles (e.g. risk-based decision making, data integrity)
Expertise in managing non-compliance, leading root-cause investigations, robust CAPA development and perform Effectiveness Checks in at least one of the GxPs (i.e. GcP). Expertise in another GxP area (GLP/GVP) is an asset.
Ability to drive collaboration and engagement across the stakeholder network, motivating others to achieve results and expertise working with service providers.
Skilled in influencing others within a global matrix organization and driving informed decision – making.
Ability to analyse data, perform trend analysis and lead meaningful discussions with business management for meeting compliance requirements.
Experience working with data analysis tools and notion of applying AI and Machine Learning in pharmaceutical industry.
Capable of prioritizing and focusing on critical issues using a risk-based approach
Manages quality and compliance issues with diligence, rigor, transparency and timeliness.
What can you expect? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to training in technical matters and soft skills. We will be your career partner for each step along the way.
R&D and Pharmacovigilance Digital Quality lead Brabant Wallon – Contracting
Our partner is looking for a R&D and Pharmacovigilance Digital Quality lead to join its team. This international company is well known for its pharmaceuticals.
What are your responsibilities?
GxP System & Technology Compliance
Ensure GLP, GCP, GVP and GRA business systems are fully compliant with regulatory expectations (e.g. OECD, ICH, GVP) and internal digital governance requirements.
Maintain and evolve the compliance framework for GxP-relevant systems (policies, SOPs, guidance).
Provide QA insight during system selection, onboarding, validation, and ongoing oversight.
Support investigations, deviations, CAPAs, and inspection-readiness activities related to DI or system failures, ensuring completeness and alignment with regulatory expectations.
External System Oversight (CRO / Vendor Systems)
Oversee the validation and lifecycle control of external computerized systems used by CROs or third-party service providers, ensuring they meet internal quality and regulatory expectations.
Collaborate with other QA teams and business stakeholders to define validation requirements, risk-based controls, and deliverables for external systems that generate or process GxP data.
Ensure appropriate documentation (URS, validation packages, data flows) is in place for external systems supporting clinical studies and activities.
Participate in vendor assessments with a focus on system integrity, validation, and compliance evidence.
End-to-End Data Integrity (DI) Governance &Compliance
Ensure end-to-end Data Integrity across all GxP-relevant data flows, from initial data capture in external partner systems through all transformations, transfers, and integrations into the company-owned environments.
Work with Computer System QA team and Clinical Operations to ensure that DI controls (including ALCOA+ principles, metadata management, audit trails, system-to-system data transfer checks, and dataflow mapping) are embedded across the full data lifecycle.
Assess and document Data Integrity risks associated with externally operated systems and the interfaces linking them to internal systems, ensuring that controls are in place to protect data reliability, and traceability.
Contribute to the development, implementation, and continuous improvement of DI practices aligned with ICH E6(R3) expectations and EMA guidance on sponsor oversight of computerized systems
Who are you?
Bachelor’s Degree required, Master’s degree preferred (IT, Engineering, Life Sciences, or related field).
Prior experience in Pharmaceutical R&D (sponsor or CRO environment) with exposure to GxP computerized systems.
Solid knowledge of GLP, GCP, GVP and GRA regulatory frameworks and associated expectations for computerized systems (e.g., OECD GLP, ICH E6(R3), EU GVP Module I/IX).
Strong understanding of Computerized System Validation (CSV) principles, including risk-based approaches and system lifecycle activities.
Familiarity with data integrity requirements (ALCOA+, metadata, audit trails, dataflow controls) and regulatory expectations for end-to-end data governance.
Experience in managing deviations, investigations, and CAPA activities within at least one GxP domain.
Ability to assess external vendor systems for compliance, validation status, and DI risk, including interpretation of validation packages and supplier documentation.
Ability to interpret complex data flows across external and internal systems and identify data integrity risks across the full lifecycle.
Strong critical-thinking and problem-solving skills with the ability to apply regulatory expectations to practical system scenarios.
Ability to work effectively with cross-functional teams to align expectations and ensure consistent compliance across shared systems.
Strong communication skills, able to convey quality concepts and DI/CSV requirements to diverse technical and non-technical stakeholders.
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.
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
