Job Province : Antwerp

• Location: Puurs
• Job #27292

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.

• Location: /
• Job #27558

Validation Project Engineer
Vast contract – Antwerpen 

Jouw verantwoordelijkheden?

De rol van Project Engineer is een uitdagende job waarbij je veel kennis opbouwt over verschillende productieprocessen en systemen en waarbij je de kans krijgt om de high level wettelijke vereisten te vertalen in een praktisch uitvoerbare en aanvaardbare approach.
Deze functie biedt veel variatie en interactie met verschillende afdelingen zoals productie, engineering, QA, ECO en site compliance.

Als Project Engineer sta je in voor volgende taken:

• Je voert validatieprojecten uit van aanpassingen aan bestaande processen
• Je onderhoudt het media fill systeem en voert vernieuwingen en verbeteringen door
• Je bent aanspreekpunt voor andere afdelingen als expert in de validatie van aseptische vulprocessen

Wie ben je?

• Bij voorkeur heb je een masteropleiding in een wetenschappelijke richting gevolgd
• Je hebt kennis van aseptische productie en affiniteit met productiesystemen
• Je bent sterk in analytisch denken en prioriteiten stellen
• Je kan ordelijk en gestructureerd werken
• Je bent een teamplayer met een positieve attitude
• Kennis van aseptische kwaliteitssystemen is een nice-to-have
• Kennis in project management en microbiologie is een troef
• Perfecte beheersing van het Nederlands en het Engels

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.

• Location: PUURS
• Job #27541

Validation Engineer
Contracting – Antwerp
 

Belangrijkste verantwoordelijkheden

• Uitvoeren van compliance-beoordelingen van dossiers voor methodevalidatie en compendiale conformiteit.

• Ondersteunen van de implementatie van nieuwe testmethoden en analytische procedures binnen Quality Control Operations.

• Coördineren en plannen van projectactiviteiten met betrekking tot laboratoriummethode-implementatie en validatie.

• Schrijven en beoordelen van protocollen, testscripts en technische rapporten.

• Beheren en documenteren van analytische afwijkingen, inclusief onderzoek en opvolging.

• Beoordelen van validatie- en methodetransfer-testresultaten om naleving van regelgeving en kwaliteitsnormen te waarborgen.

• Valideren van analytische databestanden en ondersteunende documentatie (bijv. SoftMaxPro, Excel).

• Verifiëren van naleving van farmacopoeiale (compendiale) testvereisten.

• Technische ondersteuning bieden aan QC-analisten tijdens de uitvoering van methoden.

• Oplossen van laboratoriumproblemen en uitvoeren van root cause-analyses met behulp van methodologieën zoals DMAIC.

• Deelnemen aan onderzoeken naar analytische afwijkingen, het bepalen van de hoofdoorzaken en het implementeren van corrigerende en preventieve maatregelen (CAPA).

• Ondersteunen of mede-auteur zijn van regelgevende indieningen voor nieuwe geneesmiddelen of vaccins wanneer vereist.

• Bijdragen aan initiatieven voor continue verbetering binnen laboratorium- en QC-processen.

Kwalificaties

• Masterdiploma in Industrieel Ingenieur, Burgerlijk Ingenieur, Bio-ingenieur, Industriële Farmacie, of een wetenschappelijke richting zoals Biochemie of Biotechnologie.

• Vloeiend in het Nederlands en goede kennis van het Engels (schriftelijk en mondeling).

• Sterke vaardigheden in technisch schrijven en documentatie.

• Uitstekende communicatie- en organisatorische vaardigheden.

• Hoge mate van nauwkeurigheid en oog voor detail.

• Sterk analytisch denkvermogen en probleemoplossende vaardigheden.

• Ervaring in een GMP-gereguleerde omgeving is sterk gewenst.

• Vermogen om effectief te werken in een crossfunctionele teamomgeving.

• Meerdere jaren relevante ervaring binnen een farmaceutische, laboratorium- of productieomgeving wordt als een pluspunt beschouwd.

• Location: PUURS
• Job #27540

Laboratory Operations Project Engineer
Contracting – Antwerp

Key Responsibilities
Method Validation & Compliance

Perform compliance assessments of method validation and compendial compliance dossiers.

Review validation and method transfer test results to ensure regulatory compliance.

Verify compendial test methods and ensure proper implementation within QC operations.

Validate supporting data files and tools (e.g., SoftMaxPro, Excel).

Project Coordination & Implementation

Coordinate and plan activities for the implementation of new analytical methods and procedures.

Ensure proper documentation and adherence to internal procedures and GMP requirements.

Collaborate with cross-functional teams to ensure timely execution of projects.

Documentation & Reporting

Write and review validation protocols, testing scripts, and technical reports.

Manage and document analytical deviations according to quality procedures.

Support regulatory documentation and may co-author submissions for new medicines or vaccines.

Investigation & Problem Solving

Investigate analytical deviations and laboratory issues efficiently and thoroughly.

Perform root cause analysis using structured methodologies such as DMAIC.

Initiate and follow up corrective and preventive actions (CAPA) to resolve quality-related deficiencies.

Operational Support

Provide technical support to QC analysts during test execution.

Conduct troubleshooting of analytical methods and laboratory equipment issues.

Contribute to continuous improvement initiatives within laboratory operations.

Qualifications
Education

Master’s degree in:

Industrial Engineering, Civil Engineering, or Bio-Engineering

Industrial Pharmacy

Biochemistry, Biotechnology, or a related scientific field

Experience

Several years of relevant experience in a pharmaceutical, biotechnology, or production environment is preferred.

Experience working in a GMP-regulated environment is strongly desired.

Skills & Competencies

Strong technical writing skills for protocols, reports, and validation documentation.

Excellent analytical and problem-solving abilities.

Strong communication skills (written and verbal).

High level of accuracy and organizational ability.

Team player with strong interpersonal skills.

Languages

Fluent Dutch (written and spoken).

Good command of English (written and spoken).

 

• Location: PUURS
• Job #27501

Launch Excellence Project Engineer

Antwerpen – Contracting

Mission:
The Launch Excellence Project Engineering service is responsible for managing validation activities related to the introduction of new products at the manufacturing site.
The role ensures that all processes linked to product launch comply with regulatory requirements, internal quality standards, and GMP guidelines throughout the product lifecycle.
The service also contributes to project coordination, risk management, and quality investigation activities required for successful product implementation.
Key Responsibilities:

• Validation Activities
• Plan, execute, and document validation activities associated with new product introduction.
• Validate processes related to: formulation, filling, shipping, packaging
• Ensure validation documentation complies with GMP and regulatory standards.
• Execute and document urgent quality investigations.
• Analyze deviations, identify root causes, and implement corrective actions.
• Ensure traceability and documentation of all investigations.
• Conduct risk assessments for processes and systems.
• Identify potential risks related to product implementation.
• Define and implement risk mitigation strategies.
• Support process changes and system updates related to new product introduction.
• Collaborate with cross-functional teams to implement improvements.
• Coordinate project activities related to product launch.
• Plan timelines, deliverables, and project milestones.
• Track progress and resolve issues.
• Provide project status reporting to stakeholders.
• Prepare technical and validation documentation.
• Ensure documentation meets regulatory and internal quality requirements.
• Maintain organized and auditable project records.

Profile:

• Master’s degree in a scientific discipline
• Fluency in Dutch & English
• Validation processes and documentation
• Risk assessment methodologies
• Quality investigation and deviation analysis
• Knowledge of Good Manufacturing Practices (GMP)
• Project planning and coordination
• Technical report writing
• Work may require flexibility for shift work depending on project needs.
• Collaboration with multiple departments (quality, manufacturing, engineering, regulatory).

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: /
• Job #27437

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.

 

• Location: Puurs
• Job #27406

Project Engineer – Pharmaceutical
Antwerpen – contracting 

What are your responsibilities?

• 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.