Clean Utilities Lead

vor 1 Woche


Bern, Bern, Schweiz Project Delivery Partners Vollzeit
Clean Utilities Lead

Job Description:

Job Summary
The function will be to plan, supervise and manage all works associated with all Clean Utility CQV documentation, walkdown, commissioning and qualification of the following systems:

  • Clean Utilities:
  • WFI Generation Systems
  • WFI Storage Tanks
  • WFI Distribution
  • Clean Steam Generators
  • Clean Steam Distribution
  • O2/ CO2/ N2 Distribution
  • Compressed Air (Oil Free) Distribution

Main responsibilities

Exclusions
Document preparation being completed by others.

Key Performance Indicators

  • Strong knowledge and experience of Facilities and Utilities Commissioning and Qualification in a Biotech or Biologics Manufacturing environment.
  • Management: Compliance with schedule at a system and area level with the planned resource levels.
  • Feedback from customer (i.e. Quality, HSE, operations)
  • Safety: No lost time accident
  • Quality: well executed testing with minimum rework and reexecution.

Ideal Background

  • Education (minimum/desirable): Minimum BS in Engineering or Facility Management preferably in Chemical, Mechanical, Facility, Industrial, Quality or Pharmaceutical Engineering.
  • SME Clean Utility systems.
  • Has lead teams, managed schedule and reported to management on team performance.
  • Languages: English fluent in speaking and writing.
  • Experience: Minimum 8 yrs. plus of Biotech or Pharmaceutical cGMP experience is required.
  • Broad knowledge of engineering disciplines, commissioning, compliance, qualification and quality aspects of biopharma or pharmaceutical manufacturing.
  • Has successfully defended systems before FDA, EMA etc. inspections.
  • CQV documentation experience Using KNEAT Software an advantage
  • Experience in using Delta V, PI Historian and PLC Systems essential
  • Excellent technical writing skills. Expert GMP/QA knowledge.
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