Expert in Equipment Qualification and Process Validation | Expert*in Equipment Qualifizierung und Prozessvalidierung (w/m/d)
Siemens AG
Job Summary
Join Siemens Healthineers as an Expert in Equipment Qualification and Process Validation to ensure the global supply of high-quality In-vitro Diagnostics (IVD) products while meeting stringent regulatory requirements. In this 12-month fixed-term role, you will be a key member of the validation team, responsible for implementing regulatory mandates tied to IVD manufacturing. Day-to-day tasks include acting as the primary contact for Equipment Qualification, Room Qualification, and Process Validation across departments. You will utilize your process expertise to conduct detailed risk analyses, define comprehensive validation strategies, and independently plan and coordinate all validation activities (IQ, OQ, PQ) to ensure timely market release. A core responsibility is documenting all activities according to Good Documentation Practice (GDP) and presenting validation projects during internal and external audits. Success requires a background in engineering or natural sciences, several years of experience in a regulated medical technology environment, and strong German and English communication skills.
Required Skills
Education
Completed Bachelor's degree in natural sciences or engineering, or comparable qualification. Alternatively, completed vocational training combined with long-term professional experience in the specified area.
Experience
- Several years of professional experience in a regulated environment (Pharma or Medical Technology)
- Relevant practical experience in Equipment Qualification, Room Qualification, and Process Validation
- Experience in project management of relocation projects
Languages
Additional
- Fixed-term contract (12 months). Local presence required; only a small percentage of tasks can be completed via home office. Must possess knowledge of regulatory requirements including GMP, IVDR, and ISO 13485.
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