GMP Qualification Specialist - Manufacturing Support | Qualifizierer in der Herstellung GMP Support (m/w/d)
Office Events P & B GmbH
Job Summary
This role involves working within an interdisciplinary project team focused on the renovation and relocation of laboratory and cleanroom facilities for a pharmaceutical company in Idar-Oberstein. The successful candidate will be responsible for the planning, execution, and documentation of re-qualifications and change qualifications, including computer system validations (CSV). A key part of the daily routine is ensuring that all technical equipment and utilities, such as compressed air and CO2 supply systems, meet current Good Manufacturing Practice (GMP) standards following facility modifications. This position is ideal for professionals with a strong technical background in biotechnology or process engineering who enjoy structured, goal-oriented work in a highly regulated environment. The role offers an attractive salary package and the opportunity for permanent takeover after an initial 18-month period, making it a stable career move in the life sciences sector.
Required Skills
Education
University degree in Natural Sciences, Biotechnology, Process Engineering, or a comparable qualification.
Experience
- Several years of professional experience in GMP qualification of equipment and systems
- Practical experience in User Requirement Specifications (URS), Risk Assessment (RA), and Design Qualification (DQ)
- Experience in computer system validation (CSV) within a regulated environment
- Professional background in the pharmaceutical industry or biotechnology sector
Languages
Additional
- The position is initially limited to 18 months via employee leasing with a clear option for permanent takeover. Location: Idar-Oberstein.
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