Technical Project Manager

vor 5 Stunden

Visp, Schweiz Panda International Vollzeit

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

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

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

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

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

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

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

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

  8. 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).

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

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

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

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

  13. Provide regular updates and technical reports to project stakeholders.

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

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

PROFILE

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

  2. 5+ years of experience in biopharmaceutical manufacturing, with a strong focus on technical project management or operational excellence.

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

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

  5. Strong knowledge of GMP regulations and biopharmaceutical manufacturing processes.

  6. Proficiency in project management tools and methodologies.

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

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

  9. 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

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