Engineering Project Manager
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Engineering Project Manager for CSL Behring in Bern
We make it GmbH is a company operating nationally in Switzerland which, thanks to many years of successful experience, has a high level of expertise in the personnel services sector.
Its recruitment activities are focussed on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.
For our client, CSL Behring, based in Bern, we are looking for an Engineering Project Manager (m/f/d).
Engineering Project Manager (m/f/d)
Background:
CSL Behring AG in Bern specialises in the manufacture of drugs for the treatment of immune deficiencies and immune dysfunction, as well as drugs for rhesus prophylaxis and albumin solutions for shock and burn victims. CSL Behring AG's production facilities are licensed by the Swiss health authorities and the US FDA. Every year, therapeutically important proteins are isolated from over six million litres of human plasma in accordance with the strictest safety and quality standards and processed into medicines. The products of CSL Behring AG are distributed worldwide.
Tasks:
- 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
Qualifikation:
- 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
