Strategic CAPEX Project Lead

Vor 4 Tagen

Bern, Bern, Schweiz Gi Group SA Vollzeit
Job Description

We are seeking a highly skilled CAPEX Project Lead to oversee projects in a GMP environment, with a strong understanding of automation systems.

The ideal candidate will have experience in leading CAPEX projects, managing multi-disciplinary teams, and ensuring compliance with cGMP requirements.

Responsibilities will include leading project activities, moderating team efforts, and providing cGMP compliant processes and facilities.

  • Leading CAPEX projects with a focus on automation systems, including 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 and utilities' systems.
  • Moderating and organizing multi-disciplinary teams and activities through project life cycle activities to deliver project scopes and meet global and local strategic requirements.
  • Understanding of interfaces between automation systems and process equipment, utilities systems, and 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.

Your Profile

  • 5+ years of practical and leadership experience in the pharmaceutical industry, including direct management experience in Manufacturing, Engineering, or Execution Systems' function.
  • Proven understanding of automation systems related to the pharmaceutical business.
  • Functional knowledge of cGMPs and manufacturing operations in FDA regulated facilities, understanding of GMP requirements related to automation systems and related principles (data integrity, ERES, compliance to 21 CFR Part 11).
  • Understanding of project management principles, project life cycle phases, and stage gate methodology.
  • Ideal experience with Trackwise.
  • Strong organizational skills.
  • Excellent teamwork and communication skills.
  • Proficiency in German and English.

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