In this role, you, as a Validation Engineer, will be responsible for reviewing and writing periodic review reports of different DSP equipment, guaranteeing compliance quality policies. You will check and control the qualified state of equipment that is used for manufacturing under GMP conditions and using that information, resolve the gaps that are found during the reviews.
- Support in Technical documentation for equipment qualification, maintenance and retirement, guaranteeing compliance with quality policies.
- Maintain the qualification planning.
- Support in in establishing the periodic review program in collaboration with internal and external parties, providing the technical information for contractual terms as needed.
- Participates in site and global quality improvement projects and acts as a point of contact for DSP equipment.
- Supports lab investigations process as needed.
- Assures that documentation is drafted and reviewed/approved according to MSD guidelines.
- Participation in cross-functional/global teams.
- Actively pursue information from within the Merck network for best practices.
- Engineering or scientific background.
- Strong technical writing and oral communication skills.
- Bachelor's / Master's degree in (Bio)process Engineering or comparable field of education
- Passion for Lean and continuous improvement (preferable Certified Greenbelt).
- Strong focus on quality/ compliance.
- Focus on results while balancing priorities.
- Ability to align with all levels in the organization.
- Good verbal and written communication skills in both Dutch and English.