Plant Engineer

About the role

GXP Consulting Switzerland is seeking a Plant Engineer to support its pharma and biotech clients throughout the product life‑cycle. You will work closely with cross‑functional teams to ensure that plant equipment and processes meet the highest standards of quality, safety, and regulatory compliance.

Key responsibilities

• Develop and review engineering documentation such as URS, Functional & Technical Specifications.
• Coordinate with vendors and suppliers to verify that design requirements are fulfilled.
• 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 confirm system specifications.
• Collaborate with Production, QA, Validation and other departments to maintain accurate documentation under 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, especially Fill & Finish aseptic operations.
• Strong knowledge of EU GMP Annex 1 and cGMP requirements.
• Proven experience working with equipment suppliers and external partners.
• Familiarity with project execution phases from design through commissioning.
• Excellent analytical, problem‑solving and communication skills.
• Fluent in spoken and written German.

Required skills

• URS development
• Functional & Technical Specifications
• PFD and P&ID creation and review
• Engineering calculations
• FAT and SAT participation
• Equipment selection and procurement
• EU GMP Annex 1 compliance
• cGMP knowledge

What we offer

• Collaborative, multicultural environment with continuous learning opportunities.
• Competitive salary package aligned with industry standards.
• Professional growth through internal and external training.