Job Title:
Technical Project Manager
A global market leader in the production and process support of active pharmaceutical ingredients is seeking a Technical Project Manager for a 6-month contract with possibility for extension based in the Valais area, Switzerland.
Main Responsibilities:
1. Project Scope and Strategy Development:
* Define 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 comprehensive roadmap for the project lifecycle from conceptual design through performance qualification (PQ).
2. Technical Leadership:
* Act as 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.
3. Quality and Compliance Oversight:
* Evaluate that all project activities comply with GMP regulations and internal quality standards.
* Collaborate with QA teams to manage GMP change control processes including preparation review and approval of Technical Change Requests (TCRs) and Change Records (CRs).
4. Cross-Functional Coordination:
* Liaise with operations maintenance engineering and quality teams to ensure seamless integration of mechanical adaptations into production.
* Facilitate communication and alignment between production staff and EPCM to address any technical challenges or deviations.
5. Project Execution and Monitoring:
* Monitor progress of technical and operational activities to ensure milestones are met on time and within scope.
* Conduct risk assessments and develop mitigation plans for potential project roadblocks.
* Provide regular updates and technical reports to project stakeholders.
6. Testing and Qualification:
* Lead 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 effectiveness and reliability of implemented changes.
Qualifications and Experience:
* Rlevant working/residency permit or Swiss/EU-Citizenship required.
* Bachelor's or Master's degree in Biochemical Engineering Mechanical Engineering Life Sciences or related field.
* 5+ years of experience in biopharmaceutical manufacturing with 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 ability to manage technical challenges in fast-paced environment.
* Effective communication and interpersonal skills to coordinate cross-functional teams.
* Detail-oriented with strong organizational skills for managing multiple workstreams.