Technical Project Manager

On behalf of our client, a global leader in the life sciences industry, we are looking for a Technical Project Manager to drive key capital investment initiatives within a commercial mammalian cell production line. This role will bridge operational excellence, GMP compliance, and engineering leadership to ensure successful project execution and long-term production impact.

Project Strategy & Lifecycle Management:

• Define technical project scope, success criteria, and strategic roadmap in alignment with GMP and operational goals.
• Drive project lifecycle from conceptual design through to performance qualification (PQ).
• Integrate mechanical adaptations and operational improvements into the overall CapEx investment plan.

Technical & Cross-Functional Leadership:

• Serve as the key technical contact for all project activities, coordinating closely with EPCM partners.
• Align engineering deliverables with production and quality requirements.
• Guide and support production staff on implementing operational enhancements.

GMP & Quality Oversight:

• Ensure full compliance with GMP standards and internal quality protocols.
• Prepare and manage change documentation, including Technical Change Requests (TCRs) and Change Records (CRs), in collaboration with QA.

Stakeholder Coordination:

• Act as liaison between operations, maintenance, quality, and engineering teams.
• Facilitate effective communication between internal stakeholders and EPCM contractors to resolve challenges and drive alignment.

Execution & Risk Management:

• Monitor timelines, budgets, and deliverables across technical workstreams.
• Conduct risk assessments and define mitigation strategies.
• Provide regular updates and technical reports to senior stakeholders.

Commissioning & Qualification:

• Lead planning and execution of commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Collaborate with validation teams to ensure robust CQV processes and outcomes.

Education:

• Bachelor’s or Master’s degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or related discipline.

Experience & Skills:

• 5+ years of experience in biopharmaceutical manufacturing, with a strong focus on GMP project management.
• Proven track record in operational excellence and technical project delivery.
• Hands-on experience in equipment CQV in a GMP-regulated environment.
• Deep knowledge of biopharmaceutical production processes and regulatory standards.
• Strong communication skills and ability to lead cross-functional initiatives.
• Proficiency in project management tools and methodologies.
• Fluency in English required; German is an asset.

• A key role in a globally impactful investment project within a cutting-edge life sciences environment.
• A dynamic and collaborative setting with opportunities for professional growth and cross-functional engagement.