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

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