GMP Compliance & Qualification Engineer | Engineer Compliance & Qualification GMP (m/w/d)
Office Events P & B GmbH
Job Summary
This role is based in Mainz within the pharmaceutical industry, focusing on the commissioning and (re-)qualification (C&Q) of facilities, clean rooms, and equipment across production, utility, and laboratory environments. As a GMP Compliance & Qualification Engineer, you will be responsible for ensuring technical GxP compliance and managing documentation according to Good Documentation Practice (GDocP). Your daily tasks will include initiating and tracking deviations, changes, and CAPAs, as well as coordinating external service providers. You will also serve as a key point of contact for technical GMP questions and participate in audits and inspections. This position is particularly attractive due to its competitive salary range of €70,000 - €80,000, a hybrid work model with two days of home office per week, and the long-term prospect of permanent employment following an initial 12-month contract.
Required Skills
Education
University degree in Engineering (e.g., Process Engineering, Chemical Engineering), Biotechnology, or Pharmacy.
Experience
- Professional experience with quality management systems and engineering compliance
- Proven experience in participating in audits and inspections within a regulated environment
- Experience in the initiation, processing, and tracking of deviations, changes, and CAPAs
- Practical experience in commissioning and (re-)qualification of pharmaceutical equipment and clean rooms
- Experience in coordinating external service providers for technical activities
Languages
Additional
- Availability to work in Mainz; willingness to work under a temporary employment contract (Arbeitnehmerüberlassung) with a 12-month initial term; ability to work 40 hours per week with a 2-day home office option.
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