CAPEX Project Manager

Vor 7 Tagen

Bern, Bern, Schweiz Gi Group SA Vollzeit
Job Description

We are seeking a highly experienced Project Manager to lead CAPEX projects in a GMP environment, with a strong focus on automation systems.

Key Responsibilities
  • Lead CAPEX projects focused 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.
  • Moderate and organize multi-disciplinary teams and activities through project life cycle activities to deliver project scopes that meet global and local strategic requirements.
  • Understand interfaces between 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.
  • Generate regular project reports (financial updates, project schedules, risks, and summary of current activities) for senior site management and Global Steering Committees.
Requirements
  • 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.
Company Information

Gi Group SA is a leading recruitment agency specializing in the life sciences industry.

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