Capex Automation Project Manager
Vor 6 Tagen
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 focusing on automation systems, including new systems or upgrades/extensions of existing systems.
- Responsible for project activities required to scope, develop, procure, install, and qualify automation systems used in pharmaceutical manufacturing processes and utilities’ systems.
- Moderating and organizing multi-disciplinary teams and activities throughout project life cycle activities to deliver project scopes that meet global and local strategic requirements.
- Understanding interfaces between automation systems and process equipment/utilities systems, as well as interfaces to IT systems/MES.
- Responsible for providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval.
- Generating 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 the pharmaceutical business.
- Functional knowledge of cGMPs and manufacturing operations in FDA regulated facilities, including GMP requirements related to automation systems and related principles (data integrity, ERES, compliance to 21 CFR part 11, etc.).
- Ideally, experience with Trackwise.
- 5+ years of practical and leadership experience in the pharmaceutical industry, including direct management experience in Manufacturing, Engineering, or Execution Systems functions.
- 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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