CAPEX Project Engineer – Biopharma Manufacturing

About the role

We are looking for an experienced CAPEX Project Engineer to lead capital investment projects in a commercial mammalian cell production environment. The role blends technical expertise, operational excellence, and project management to deliver mechanical adaptations, operational improvements, and GMP‑compliant project execution.

Key responsibilities

• Define technical project requirements, success criteria, and implementation strategies aligned with GMP standards.
• Support and coordinate capital investment projects, ensuring delivery on time, within scope, and on budget.
• Act as the primary technical contact for mechanical adaptations, operational improvements, and production‑related engineering activities.
• Collaborate with Operations, Maintenance, Engineering, Validation, and QA teams throughout the project lifecycle.
• Manage GMP change control activities, including Technical Change Requests (TCRs) and Change Records (CRs).
• Lead commissioning and qualification activities (IQ, OQ, PQ) and conduct risk assessments.
• Provide technical guidance and regular project updates to stakeholders.

Required profile

• Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or related discipline.
• Minimum 5 years of experience in biopharmaceutical manufacturing or GMP‑regulated environments.
• Strong background in technical project management, operational excellence, and capital project execution.
• Hands‑on experience with commissioning, qualification, and validation activities.
• Fluent in German and English.

Required skills

• GMP compliance
• Technical Change Requests (TCR) and Change Records (CR) management
• Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
• Commissioning, qualification, and validation (CQV) activities
• Risk assessment and mitigation planning