GMP Compliance & Qualification Engineer | Engineer Compliance & Qualification GMP (m/w/d)
Office Events P & B GmbH
Job Summary
This role involves overseeing commissioning and (re-)qualification (C&Q) activities for facilities, clean rooms, and equipment within a pharmaceutical environment in Mainz. The successful candidate will be responsible for ensuring technical GxP compliance across production, utility, and laboratory settings. Daily tasks include the creation of plans and reports in accordance with Good Documentation Practice (GDocP), managing engineering change controls, handling deviations, and implementing CAPAs. You will serve as a key point of contact for technical GMP questions and coordinate with external service providers for qualification tasks. This position is particularly attractive due to its competitive salary range of €70,000 - €80,000, the option to work from home two days per week, and the potential for permanent takeover after the initial 12-month contract. It offers a structured professional environment within the biotechnology and pharmaceutical sector, focusing on high-quality standards and modern IT systems.
Required Skills
Education
University degree in Engineering (e.g., Process Engineering, Chemical Engineering), Biotechnology, or Pharmacy.
Experience
- Professional experience with GxP regulations in the biotechnological or pharmaceutical industry
- Proven experience with Quality Management Systems and Engineering Compliance
- Experience participating in audits and inspections
- Practical experience in initiating and tracking deviations, changes, and CAPAs
- Experience in commissioning and (re-)qualification of facility, clean room, and laboratory equipment
Languages
Additional
- Initial 12-month fixed-term contract with option for extension or permanent hire; Home office option available (2 days/week); Full-time (40 hours/week) located in Mainz; Experience with modern IT systems required.
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