Capex Automation Project Manager H/F
We are looking for a Project Manager with experience in leading CAPEX projects in a GMP environment and having specifically a strong understanding of automation systems.
Your responsibilities : - Leading CAPEX projects having their focus on automation systems, that will BE new or existing systems to BE upgraded or extended.
- Responsible for project activities required to scope, develop, procure, install, and qualify automation systems used in pharmaceutical manufacturing processes / utilities' systems- Moderates and organizes multi-disciplinary teams and activities through project life cycle activities to deliver project scopes to meet global and local strategic requirements.
- Understanding of interfaces between the automation systems and process equipment / utilities systems and interfaces to IT systems / MES.
- Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval.- Generation of regular project reports (financial updates, project schedules, risks and summary of current activities) for senior site management and Global Steering Committees
Required qualifications : - Proven understanding of automation systems related to pharmaceutical business- Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility.
Understanding of GMP requirements related to automation systems, and related principles (data integrity, ERES, compliance to 21-part part 11)- Ideally experience with Trackwise- 5+ years practical and leadership experience in pharmaceutical industry including direct management experience in Manufacturing, Engineering or Execution Systems' function.
- Understanding of project management principles, project life-cycle phases and stage gate methodology.- Proficiency in German and English.
- Strong organizational skills- Excellent teamwork and communication skills.
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