Pharma Plant Engineer: Equipment, Commissioning & GMP

GXP CONSULTING Switzerland; Bern; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

GXP CONSULTING Switzerland is seeking a Plant Engineer to join our Bern-based life sciences team. You will drive engineering activities from concept through start-up, developing robust documentation and coordinating with production, QA, and validation groups.

Ideal candidates have 5–10 years in pharma/biotech with strong Fill & Finish aseptic experience and deep knowledge of engineering docs like URS, FS, TS, PFDs and P&IDs, as well as EU GMP Annex 1 and cGMP requirements.

Qualifikationen

• Degree in Engineering (Chemical, Mechanical, or related field).
• 5–10 years in pharma/biotech, with strong Fill & Finish aseptic experience.
• Strong knowledge of engineering documentation (URS, FS, TS, PFDs, P&IDs, layouts).
• Strong knowledge of EU GMP Annex 1 and cGMP requirements.

Aufgaben

• Develop and review engineering documentation (URS, Functional & Technical Specifications).
• Coordinate with vendors and suppliers to ensure design requirements are met.
• Review and approve PFDs, P&IDs, layouts, and engineering drawings.
• Perform and validate engineering calculations and design assumptions.
• Support equipment selection, procurement, and technical alignment with suppliers.
• Participate in FAT and SAT to ensure systems meet specifications.
• Collaborate with cross-functional teams (Production, QA, Validation, etc.).
• Ensure documentation is accurate and maintained in line with change control processes.
• Contribute to project execution from concept through implementation.
• Provide technical support during commissioning and start-up phases.

Kenntnisse

Pharma/biotech experience

Aseptic expertise

Engineering documentation

Strong communication

Ausbildung

Engineering degree (Chemical/Mechanical)

Jobbeschreibung

GXP CONSULTING Switzerland is seeking a Plant Engineer to join our Bern-based life sciences team. You will drive engineering activities from concept through start-up, developing robust documentation and coordinating with production, QA, and validation groups.

Ideal candidates have 5–10 years in pharma/biotech with strong Fill & Finish aseptic experience and deep knowledge of engineering docs like URS, FS, TS, PFDs and P&IDs, as well as EU GMP Annex 1 and cGMP requirements.