Plant Engineer

About the role

GXP Consulting Switzerland is seeking a Plant Engineer to join its Life Sciences team. You will support clients across the full product life‑cycle, focusing on fill‑and‑finish aseptic operations within the pharma/biotech sector.

Key responsibilities

• Develop and review engineering documentation such as 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 Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to verify 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 Engineering (Chemical, Mechanical, or related field).
• 5–10 years of experience in pharma/biotech, with strong fill‑and‑finish aseptic background.
• Deep knowledge of EU GMP Annex 1 and cGMP requirements.
• Proven experience working with equipment suppliers and external partners.
• Familiarity with project execution phases (design, procurement, FAT/SAT, commissioning).
• Strong analytical, problem‑solving, and communication skills.
• Fluent in English, both spoken and written.

Required skills

• Engineering documentation (URS, FS, TS, PFDs, P&IDs, layouts).
• EU GMP Annex 1 and cGMP compliance.
• Fill‑and‑finish aseptic processes.
• Equipment selection and procurement.
• FAT and SAT execution.
• Commissioning and start‑up support.

What we offer

• Human‑sized, multicultural work environment.
• Opportunities to contribute to ambitious international projects.
• Continuous learning via internal and external training.
• Competitive salary package with exceptional benefits.