Plant Engineer (Pharma/Biotech)

About the role

GXP Consulting Switzerland is seeking an experienced Plant Engineer to support its pharmaceutical and biotech clients. The role focuses on the design, documentation, and commissioning of aseptic fill‑and‑finish facilities, ensuring compliance with GMP standards.

Key responsibilities

• Develop and review engineering documentation such as URS, functional and technical specifications.
• Coordinate with vendors and suppliers to verify that design requirements are satisfied.
• Review and approve PFDs, P&IDs, layouts, and engineering drawings.
• Perform engineering calculations and validate design assumptions.
• Support equipment selection, procurement, and technical alignment with suppliers.
• Participate in Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to confirm system specifications.
• Collaborate with cross‑functional teams including Production, QA, and Validation.
• Maintain accurate documentation in line with change‑control processes.
• Provide technical support during commissioning and start‑up phases.

Required profile

• Degree in Chemical, Mechanical, or related engineering discipline.
• 5–10 years of experience in pharma/biotech, with strong Fill & Finish aseptic background.
• Deep knowledge of EU GMP Annex 1 and cGMP requirements.
• Proven experience working with equipment suppliers and external partners.
• Familiarity with all project execution phases from design to commissioning.
• Fluent in spoken and written German.

Required skills

• URS, Functional & Technical Specifications
• PFD, P&ID, layout and engineering drawing review
• Engineering calculations and design validation
• Equipment selection and procurement
• FAT and SAT execution
• EU GMP Annex 1 compliance
• cGMP knowledge
• Fill & Finish aseptic processes

What we offer

• Competitive salary aligned with industry standards
• Comprehensive benefits package
• Opportunities for continuous learning and professional development
• Collaborative, multicultural work environment