Commissioning Expert

5 days ago

Melbourne, Victoria, Australia beBeeValidation Full time $105,000 - $155,000
Senior Commissioning Specialist

The Senior Commissioning Specialist ensures systems, facilities, and equipment meet design requirements. This role is accountable for the execution of the company's mission to maintain product and service integrity while enabling growth.

  • Leverage leadership skills to simplify commissioning functions, reports, and processes.
  • Support implementing safety programs for major capital projects.
  • Commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
  • Create controlled documents for commissioning projects.
  • Review and qualify equipment for commissioning activities.
  • Write and review technical specifications and quality management documents.
  • Collaborate with multiple departments on assigned project activities and deliverables.
  • Initiate and coordinate risk analyses, design reviews, and FAT/SAT/PQ executions.
  • Contact and work with contractors and vendors on assigned projects.
  • Travel as needed.
Requirements
  • Bachelor's Degree in Engineering or Life Science.
  • 7-10 years of applicable work experience in biomed and pharmaceuticals.
  • Author and execute DQ, IQ, OQ, PQ, and PV documents.
  • Develop SOPs, final reports, and validation & quality policies.
  • Strong experience developing commissioning protocols and maintaining policies and processes.
  • Compliance with cGMPs and CFR21 Part 11 guidelines.
  • Demonstrated strategic thinking and implementation skills.
  • Excellent presentation and communication skills.
  • Highly organized in planning and time management.

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