Technical Project Manager
On behalf of our client, a global leader in the life sciences industry, we are seeking a Technical Project Manager to oversee key capital investment initiatives within a commercial mammalian cell production line. This role bridges operational excellence, GMP compliance, and engineering leadership to ensure successful project execution and long-term production impact.
Key Responsibilities:
1. Project Strategy & Lifecycle Management:
* Define technical project scope, success criteria, and strategic roadmap aligned 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.
2. Technical & Cross-Functional Leadership:
* Serve as 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.
3. 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.
4. 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.
5. 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.
6. 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.
Requirements:
* Bachelor's or Master's degree in Biochemical Engineering, Mechanical Engineering, Life Sciences, or related discipline.
* 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.
What We Offer:
* 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.