Mark this as favouriteValidation Engineer - CSV

We are seeking an experienced a MES Validation Engineer to join our team and provide quality oversight across multiple MES projects. In this role, you will act as an MES Qualification/Validation Specialist, supporting a team of Quality Engineering professionals and ensuring compliance with GMP and regulatory expectations.

This position is for someone with strong CSV expertise, excellent communication skills, and hands‑on experience with Werum PAS‑X.

What We Offer

• Temporary agency contract for 12 months via Grafton (based on CLA ABU), with potential extension
• Start date: ASAP
• Salary: € 6.930,- gross per month based on 40 hours (excl. 8% holiday allowanc, 25 vacation days, paid public holiday, pension)
• Travel reimbursement (OV fully covered or € 0,23 per km up to 100 km/day, max € 410 per month)
• Opportunity to work in a high‑tech, fast‑paced biopharmaceutical environment

Key Responsibilities

• Support the development of KPIs to drive continuous improvement initiatives
• Develop strategies to implement process changes across the organization
• Review and approve all CSV deliverables, including initial validation, change‑based validation, and periodic revalidation
• Build and maintain working engineering knowledge of products and systems
• Collaborate effectively across functions and contribute to organizational processes
• Prioritize workload to meet departmental goals with minimal supervision
• Perform a wide range of activities to ensure compliance with regulatory requirements
• Maintain programs and processes to ensure high‑quality products and adherence to GMP
• Identify deviations from accepted practices and perform impact assessments
• Work directly with operational teams to support inspections, SPC analyses, and audits
• Assist with compliance audits as needed
• Support CQV quality oversight activities and Quality Risk Management processes

Required Experience

• Demonstrated proficiency in Quality Engineering principles, industry standards, and best practices
• Strong verbal communication, technical writing, and interpersonal skills
• Mandatory: Hands‑on experience with Werum PAS‑X

Preferred Experience

• Knowledge of Six Sigma and DMAIC methodology
• Familiarity with performance measures and quality improvement statistics
• Proficiency with Risk Management tools such as HACCP and/or FMEA

Interested?

Apply today! Or feel free to contact:

Audrey Poluakan - Recruitment Consultant Gi Life Sciences

M: 0658069570

E: audrey.poluakan@gigroup.com