Engineering Project Manager
m / f / d)
Freelance / temporary employment for a project Bern Start date : asap Reference number : 772957 / 1
Diesen Job teilen oder drucken
Responsibilities
- 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
Profile
Proven knowledge regarding Sterility Assurance driven projects and the revised EU GMP Annex 1 Manufacture of Sterile Medicinal ProductsMS / MBA / BS / BA in Engineering, Business Administration or Life Sciences preferred or local equivalentSolid practical and leadership experience in pharmaceutical industry including direct management experience in Manufacturing, Engineering or Quality AssuranceFunctional knowledge of cGMPs and manufacturing operations in FDA regulated facilityUnderstanding of project management principles and project life-cycle phases. Knowledge of Validation, CMC and facility regulatory submission requirementsBenefits
A highly motivated team and an open way of communicationA very renowned company