Plant Engineer - Pharma/Biotech | Growth & Global Projects

GXP CONSULTING Switzerland; Bern; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

GXP CONSULTING Switzerland is seeking a Plant Engineer to lead engineering documentation and supplier coordination for pharma/biotech projects in Switzerland. The role requires a strong background in Fill & Finish aseptic processes and extensive experience with design, procurement, FAT/SAT, and commissioning.

The candidate should hold an Engineering degree with 5–10 years of pharma experience, deep knowledge of EU GMP Annex 1 and cGMP, and excellent communication to align with cross-functional

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
• Experience working with equipment suppliers and external partners
• Familiar with project execution phases (design, procurement, FAT/SAT, commissioning)
• Strong analytical and problem-solving skills
• Good communication and stakeholder coordination abilities
• Ability to work both independently and within project teams
• Fluent in English (spoken and written)

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

EU GMP Annex 1 & cGMP

Engineering documentation (URS/FS/TS/P

Vendor & supplier coordination

Project execution (design, procurement

Analytical & problem solving

Communication & stakeholder management

English fluency

Ausbildung

Engineering degree (Chemical/Mechanical)

Jobbeschreibung

GXP CONSULTING Switzerland is seeking a Plant Engineer to lead engineering documentation and supplier coordination for pharma/biotech projects in Switzerland. The role requires a strong background in Fill & Finish aseptic processes and extensive experience with design, procurement, FAT/SAT, and commissioning.

The candidate should hold an Engineering degree with 5–10 years of pharma experience, deep knowledge of EU GMP Annex 1 and cGMP, and excellent communication to align with cross-functional