Project Engineer – CAPEX (7‑month contract)

About the role

The Project Engineer – CAPEX will lead capital investment projects for a commercial mammalian cell production line in the pharmaceutical sector. Based in the Valais region of Switzerland, the role combines technical engineering, GMP compliance and project management to deliver mechanical adaptations and operational improvements within a 7‑month fixed‑term contract.

Key responsibilities

• Define project scope, technical requirements and success criteria aligned with GMP standards and operational goals.
• Develop and maintain a project roadmap from concept through performance qualification (PQ).
• Act as the primary technical liaison for mechanical adaptations, supporting production staff during implementation.
• Ensure all activities comply with GMP regulations and manage change control documentation (TCRs, CRs).
• Coordinate cross‑functional teams – operations, maintenance, engineering and quality – to integrate adaptations seamlessly.
• Monitor progress, conduct risk assessments, and provide regular technical reports to stakeholders.
• Lead equipment commissioning and qualification phases (IQ, OQ, PQ) and work with validation teams.

Required profile

• Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences or related field.
• Minimum 5 years of experience in pharmaceutical or biotech capital projects.
• Eligibility to work in Switzerland (Swiss/EU citizenship or relevant permit).
• Proven ability to manage GMP‑driven projects and lead cross‑functional teams.

Required skills

• GMP compliance and change control (Technical Change Requests, Change Records).
• Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) processes.
• Risk assessment and mitigation planning.
• Project management and coordination of multidisciplinary teams.
• Mechanical engineering expertise for equipment adaptations.