Operations / Project Qualification Engineer | Betriebs- / Projektingenieur Qualifizierung (m/w/d) – Basel
Manpower
Job Summary
This role involves acting as an Operations and Project Qualification Engineer within the Pharma Engineering department, focusing on Solid Dosage forms (Solida). The successful candidate will be responsible for ensuring GMP compliance throughout the rigorous qualification lifecycle of equipment and systems. Key daily tasks include creating comprehensive Qualification Plans and Reports (DQ, IQ, OQ, PQ), executing these qualification phases, and managing GMP-compliant documentation, including handling deviations. You will also assess technical changes to systems regarding their influence on the qualified state and independently perform re-qualifications, including creating QPP and MQP documents. This position is highly attractive for professionals with deep GMP expertise and a background in engineering or natural sciences who are adept at applying quality systems efficiently within a pharmaceutical manufacturing environment in Basel.
Required Skills
Education
Completed university degree in Natural Sciences or Engineering, or equivalent relevant professional experience
Experience
- Minimum 3 years of professional experience with profound knowledge of the qualification process
- Several years of experience in the GMP environment
- Deep understanding of quality systems and their efficient implementation
Languages
Additional
- The role is GMP-relevant and involves access to Roche products. Must be able to work 80–100% (full-time equivalent) in Basel. Travel is required only based on project needs.
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