Project Engineer (CAPEX) – Biopharma Manufacturing

About the role

Proclinical is looking for a Project Engineer (CAPEX) to drive capital investment projects on a commercial mammalian cell production line. The role ensures mechanical adaptations and operational improvements meet GMP standards while delivering projects on time and within budget.

Key responsibilities

• Define technical requirements and success criteria aligned with GMP and operational goals.
• Collaborate with stakeholders to integrate operational improvements into project plans.
• Develop roadmaps from conceptual design through performance qualification (PQ).
• Serve as the primary technical contact for mechanical adaptations and guide production staff.
• Manage GMP change‑control processes, including Technical Change Requests and Change Records.
• Coordinate with operations, maintenance, engineering, and quality teams for seamless integration.
• Monitor project progress, conduct risk assessments, and implement mitigation plans.
• Lead equipment commissioning, installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) activities.
• Oversee validation teams to ensure reliability of implemented changes.

Required profile

• Degree in Biochemical Engineering, Mechanical Engineering, Life Sciences or a related field.
• Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.
• Proficiency with project management tools and methodologies.
• Hands‑on experience in commissioning, qualification and validation (CQV) in a GMP environment.
• Effective communication and interpersonal skills for cross‑functional coordination.
• Detail‑oriented, organized and capable of managing multiple workstreams.
• Problem‑solving ability in a fast‑paced environment.
• Fluency in English; German is highly preferred.

Required skills

• GMP regulations
• Biopharmaceutical manufacturing processes
• Project management tools/methodologies
• Commissioning, qualification and validation (CQV)
• Risk assessment and mitigation
• Change‑control management (Technical Change Requests, Change Records)