SL-000276
Job description:
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.
Requirements:
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.
Competences:
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.
Compensation benefits:
- 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.