Technical Project Manager

In partnership with our key pharmaceutical client in Visp, Switzerland, we are looking for a Technical Project Manager to play a critical role in overseeing the successful realization of CAPEX projects in a commercial mammalian cell production line. 

ROLE

• Define the technical requirements and success criteria for the project, ensuring alignment with GMP standards, operational goals, and compliance expectations.

• Collaborate with stakeholders to integrate operational improvements into the overall project plan.

• Develop a comprehensive roadmap for the project lifecycle, from conceptual design through performance qualification (PQ).

• Act as the primary technical point of contact for the project, ensuring all mechanical adaptations and operational improvements meet required specifications.

• Coordinate with EPCM teams to ensure alignment of engineering deliverables with technical and operational requirements.

• Provide guidance and support to production staff implementing operational improvements.

• Ensure that all project activities comply with GMP regulations and internal quality standards.

• Collaborate with QA teams to manage GMP change control processes, including the preparation, review, and approval of Technical Change Requests (TCRs) and Change Records (CRs).

• Liaise with operations, maintenance, engineering, and quality teams to ensure seamless integration of mechanical adaptations into production.

• Facilitate communication and alignment between the production staff and the EPCM to address any technical challenges or deviations.

• Monitor the progress of technical and operational activities to ensure milestones are met on time and within budget.

• Conduct risk assessments and develop mitigation plans for potential project roadblocks.

• Provide regular updates and technical reports to project stakeholders.

• Lead the planning and execution of equipment commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.

• Oversee and coordinate with validation teams to ensure the effectiveness and reliability of the implemented changes.

 

PROFILE

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

• 5+ years of experience in biopharmaceutical manufacturing, with a strong focus on technical project management or operational excellence.

• Proven experience working on GMP-compliant projects, including change management and qualification activities.

• Hands-on experience in commissioning, qualification, and validation (CQV) of equipment and processes in a GMP environment.

• Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.

• Proficiency in project management tools and methodologies.

• Excellent problem-solving skills with the ability to manage technical challenges in a fast-paced environment.

• Effective communication and interpersonal skills to coordinate cross-functional teams.

• Detail-oriented with strong organizational skills for managing multiple workstreams.
   

Interested? Know someone that might be? Don’t hesitate to reach out on v.niesov@panda-int.com!