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CAPEX project Manager f/m/d (DE)
[17719]
CAPEX, sterile, fill and finish
Project title: CAPEX project Manager f/m/d Type of employment: Payroll Industry: Biotech Skills: CAPEX,sterile,fill and finish Project start: ASAP Project duration: 12 months Location: Bern, Switzerland Tasks: ·Responsible for project activities required to scope, develop, procure, construct and qualify new equipment and facilities required to meet facility production throughput demands ·Leads multi-disciplinary Teams through project life cycle activities to deliver capacity expansion capabilities to meet global and local strategic requirements ·Develops and maintains integrated project plans and monitors project activities for adherence to milestone timelines, deliverables and budget against approved plan. ·Maintain oversight on project risks and develops risk mitigation strategies. ·Ensures that initiatives are aligned with the business objectives and strategic philosophy ·Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval ·Responsible for implementing EHS by design principles in the project ·Responsible for generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for site Sr. Management and Global Steering Committees ·Project Teams are responsible for completion of project lifecycle activities through performance qualification ·Influences teams to work collaboratively, to be customer focused and to deliver superior performance through personal leadership abilities, mentoring and effective communication. Qualifications: ·Successful studies in Engineering, Business Administration or Life Sciences (MS/MBA/BS/BA or equivalent) ·10 years of experience in managing capital projects in the pharmaceutical industry ·Ideally experience of Annex 1 and filling lines ·Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility ·Excellent understanding of project management principles and project lifecycle phases, including knowledge of Validation, CMC and facility regulatory submission requirements ·Experience to manage high level project budgets ·Ability to handle many tasks simultaneously and integrate project planning efforts across functions ·Ability to understand “the big picture” and approach problem solving in a proactive team manner ·German is mandatory