Project Manager CapEx (f/m/d) - 100%
For a worldwide leading biotherapeutics company in Bern we are looking for a
Project Manager CapEx (f/m/d) - 100%
We are looking for a Project Manager with experience in leading CapEx projects in a GMP environment and specifically with the new EU GMP Annex 1 "Manufacture of Sterile Medicinal Products".
You will be responsible and accountable for the delivery of local CapEX-projects in the field of (mainly but not limited on) Fill, Finish and Packaging from feasibility to planning, execution and qualification/validation within the remit of the global engineering and project delivery department.
Tasks and 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
Your profile
- Minimum Bachelor degree in a relevant discipline (e.g. Life Sciences, Engineering)
- At least two years of practical and leadership experience in pharmaceutical industry (Manufacturing, Engineering or Quality Assurance)
- Proven knowledge regarding Sterility Assurance driven projects and the revised EU GMP Annex 1 "Manufacture of Sterile Medicinal Products"
- 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
- German and English fluent in written and spoken
General information
- Start date: asap
- Duration of employment: initially planned for 12 months
- Place of work: Bern
- Workload: 100 %
Kontakt
Nicole Blum
Senior Consultant Life Sciences
+41 61 270 80 14
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