Qualifizierungs- und Validierungsingenieur (m/w/d)
Core
Plan and document qualification activities (DQ, IQ, OQ, PQ) and process validations for pharmaceutical and medical device clients to ensure GMP-compliant operation of equipment and processes.
Role type
Validation and Qualification Engineer
Builds
Qualified and validated equipment, processes, and validation reports for pharma/medtech clients
Domain
Life Sciences (Pharmaceuticals, Medical Devices)
Required skills
GMP compliance, Risk analysis, Validation planning, Technical documentation, Process validation, Equipment qualification
Preferred skills
Process validation experience, Cleaning validation experience, Engineering or Natural Sciences degree
Technologies
GMP, DQ, IQ, OQ, PQ
Responsibilities
Conduct GMP risk analyses, Plan and execute Design, Installation, Operational, and Performance Qualifications, Summarize results in qualification reports, Participate in process and cleaning validations, Work according to internal and external quality standards
Seniority
Junior to Mid-level, hands-on IC