CAPEX Project Manager

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 the company CSL Behing in Bern we are looking for a CAPEX Project Manager (m/f/d).

CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients needs by using the latest technologies we develop and deliver innovative therapies that treat coagulation disorders primary immune deficiencies hereditary angioedema respiratory disease and neurological disorders. The companys products are also used in cardiac surgery burn treatment and to prevent hemolytic disease of the newborn.

The position holder is responsible and accountable for the delivery of local CapEXprojects 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 (ENG / PD) department.

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 multidisciplinary 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 lifecycle 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

Requirements

• 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 lifecycle phases. Knowledge of Validation CMC and facility regulatory submission requirements

Work hours

• 41 h/ Week

Are you interested

Then Ms. Emina Becic looks forward to receiving your complete application documents (CV references and training certificates).

We look forward to hearing from you.