Mark this as favouriteValidation Engineer - CQV

Validation Engineer – CQV / Quality Oversight

Our client is a biopharmaceutical company engaged in the development of innovative cancer immunotherapy and they are an experienced a We are seeking an experienced Validation Engineer to join our team and provide quality oversight across CQV and engineering‑related projects. In this role, you will support new system introductions, ensure risk‑based validation strategies are applied, and help maintain compliance with GMP, GLP, and regulatory expectations.

This position is ideal for someone with strong Quality Engineering expertise, excellent communication skills, and the ability to work cross‑functionally in a fast‑paced environment.

What We Offer

• Temporary agency contract for 12 months via Grafton (based on CLA ABU), with potential 6 months 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

• Provide quality oversight on CQV and engineering‑related projects
• Support new system introductions by serving as a technical resource
• Develop and apply risk‑based validation strategies aligned with the Site Validation Master Plan
• Review and approve all CQV deliverables, including initial validation, change‑based validation, and periodic revalidation
• Develop strategies to implement process and system changes
• Collaborate effectively across functions and contribute to organizational processes
• Prioritize workload with minimal supervision to meet departmental goals
• 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 and GLP
• Develop solutions to complex problems and perform impact assessments
• Work directly with operational teams to support inspections, SPC analyses, and audits
• Assist with compliance audits as required
• Work independently on routine tasks and receive general guidance for new assignments

Required Experience

• BSc degree in Engineering, Life Sciences, or related field
• Demonstrated proficiency in Quality Engineering principles, concepts, industry practices, and standards
• Strong verbal communication, technical writing, and interpersonal skills

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 at Gi Life Sciences

M: 0658069570

E: audrey.poluakan@gigroup.com