Validation Engineer

Vulcain Engineering Group | Belgium; Vlaams-Brabant; Sur place; EUR 50 000 - 58 000; Plein temps

Avantages offerts par ce poste

Company car

Fuel card

Meal vouchers

Insurance

Eco cheques

Sectorial bonus

Résumé du poste

Vulcain Engineering Group in Belgium is seeking a CSV Validation Engineer (PAS-X) to lead validation activities for GMP-regulated systems, ensuring data integrity and GxP compliance across MES implementations in regulated manufacturing environments.

You will prepare and review validation plans, risk assessments, IQ/OQ/PQ protocols, coordinate testing with manufacturing, QA and IT, and support audits while driving continuous improvement of validation methodologies and digitalization of production

Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology or related field.
• 4+ years of validation experience in pharma/Life Sciences.
• Experience with PAS-X MES projects.
• Strong CSV, GAMP5 and GMP knowledge.
• Experience writing and executing validation protocols.
• Knowledge of data integrity and CSV lifecycle management.
• Ability to work autonomously with multidisciplinary stakeholders.
• Fluency in English; Dutch a plus.

Responsabilités

• Lead CSV activities for GMP-regulated systems.
• Implement, qualify and manage PAS-X MES solutions.
• Prepare and review validation documentation (IQ/OQ/PQ, URS, DS, DS, validation reports).
• Ensure data integrity and GxP compliance.
• Coordinate testing and defect management during projects.
• Collaborate with manufacturing, QA, IT and engineering teams.
• Support audits and inspections; ensure inspection readiness.
• Drive continuous improvement of validation methodologies and digitalization.

Connaissances

CSV validation

PAS-X MES

GxP compliance

Data integrity

Validation lifecycle

Autonomous work

Formation

Bachelor's or Master's in Engineering/Life Sciences

Description du poste

As part of our Life Sciences activities, we are looking for a CSV Validation Engineer (PAS-X) to support the implementation, validation and compliance of computerized systems within highly regulated pharmaceutical manufacturing environments. You will play a key role in ensuring that manufacturing execution systems (MES) and digitalized production processes comply with GxP requirements while supporting operational excellence and data integrity.

ABOUT THE POSITION:

• Lead and execute Computer System Validation (CSV) activities for GMP-regulated systems.
• Support the implementation, qualification and lifecycle management of PAS-X MES solutions within pharmaceutical manufacturing environments.
• Prepare and review validation documentation including Validation Plans, Risk Assessments, URS, FS, DS, IQ, OQ, PQ protocols and validation reports.
• Ensure compliance with GxP regulations, Data Integrity principles and applicable industry guidelines.
• Coordinate testing activities and support defect management during project execution.
• Collaborate closely with manufacturing, quality assurance, IT, automation and engineering teams throughout the validation lifecycle.
• Participate in audits and inspections by ensuring that validation deliverables are complete, accurate and inspection-ready.
• Contribute to continuous improvement initiatives related to validation methodologies, digitalization and manufacturing processes.

ABOUT YOU:

• Bachelor's or Master's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences or a related discipline.
• Minimum 4 years of experience in Validation within the pharmaceutical, biotechnology or Life Sciences industry.
• Demonstrated experience with PAS-X MES projects.
• Strong knowledge of CSV methodologies, GAMP 5 principles and GMP requirements.
• Experience writing and executing validation protocols and managing qualification activities.
• Good understanding of data integrity requirements and computerized system lifecycle management.
• Ability to work autonomously while coordinating with multidisciplinary stakeholders.
• Fluency in English is mandatory. Knowledge of Dutch is a strong asset.

ABOUT VULCAIN:

Vulcain Engineering is a group specialized in the energy sector that supports companies active in Renewable & Nuclear Energy, Gas & Infrastructure through our Study Offices and Consultancy services. Vulcain Engineering Group is positioned as a transformation partner thanks to its ultra-specialization in strategic sectors which positively impact the transformation of our society and supports its clients in their transformation towards more sustainable and responsible models. Vulcain supports its clients throughout the entire life cycle of their projects, from design to commissioning, by integrating constructability and safety requirements right from the design phase.

In Belgium, our activities focus on consultancy services, delivering expertise in three main areas:

• Energy/Infrastructure
• Gas, Renewables & Processes
• Life Sciences

With headquarters based in Brussels, and clients spread all over the country, we address key projects in the Belgian industry, offering our consultants the opportunity to work on challenging topics and discover different areas during their time at Vulcain.

Why would you apply?

• An annual gross salary ranging from 50 000€ to 58 000€ paid over 13,92 months and advantages such as a company car (and fuel card), representation fees, insurances, meal vouchers, eco cheques, a sectorial bonus (the annual salary may vary according to your exact level of experience)
• A tailored career path within the company : opportunities to discover different business units, training, follow-up from your business manager, and a development evaluation every year
• A human-based company with slightly more than 120 consultants and synergies between the different business units