Engineering Project Manager (5468 – URA)
Our client, a large pharmaceutical organization, is looking for an Engineering Project Manager for a 1-year contract (with a possibility of an extension) in Bern.
As a project Manager you should bring expertise in leading CAPEX projects in a GMP environment and specifically with the new EU GMP Annex 1 "Manufacture of Sterile Medicinal Products".
- Support to local execution lead for improvement projects regarding Sterility Assurance, aligned with Local and Global stakeholders
- Leading of CAPEX projects in the field of Filling and Finish (Visual Inspection and Packaging)
- Responsible for project activities required to scope, develop, procure, construct and qualify new equipment and facilities required to meet facility production throughput demands
- Participates in multi-disciplinary Teams through project life cycle activities to deliver capacity expansion capabilities to meet global and local strategic requirements
- Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval
- Project Teams are responsible for completion of project life-cycle activities through turnover to routine commercial production
- Support for generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for senior site management and Global Steering Committees.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- Proven knowledge regarding Sterility Assurance driven projects and the revised EU GMP Annex 1 "Manufacture of Sterile Medicinal Products"
- MS/MBA/BS/BA in Engineering, Business Administration or Life Sciences preferred or local equivalent
- 2+ years practical and leadership experience in pharmaceutical industry including direct management experience in Manufacturing, Engineering or Quality Assurance
- Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
- Understanding of project management principles and project life-cycle phases. Knowledge of Validation, CMC and facility regulatory submission requirements
- Fluency in German and English is good to have.