Senior Commissioning Specialist

3 days ago

Singapore beBeeValidation Full time $80,000 - $120,000

Job Opportunity

An experienced and skilled Senior Commissioning Specialist is required to support our clients in the Life Sciences industry.

Job Summary

We are seeking a dynamic professional with a strong background in commissioning and qualification of complex systems, including computer system validation, equipment qualification, and cleaning validation. The ideal candidate will possess excellent leadership skills, be able to work effectively in a fast-paced environment, and have a deep understanding of industry standards and regulations.

  • Planning and Coordination: Coordinate planning activities for equipment qualification, computer system validation, temperature-controlled objects (freezers, incubators), clean utilities validation, and cleaning validation in accordance with industry standards.
  • Qualification Activities: Perform FAT, SAT, IQ, OQ, PQ protocols and reports for existing manufacturing process equipment, package units, commercial off-the-shelf analytical instruments, freezers, and other related equipment.
  • Lifecycle Documentation: Develop and manage equipment qualification and analytical instruments lifecycle documentations, e.g., FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, technical specifications.
  • Investigation and Troubleshooting: Lead investigations revolving around discrepancies identified during qualification activities.

Key Requirements

The successful candidate will have:

  • Validation Expertise: Relevant experience in validation activities, including creation, pre-execution approval, execution, post-execution review, and post-execution approval of all validation lifecycle documents.
  • Leadership Skills: Excellent leadership skills, with the ability to lead daily validation meetings with cross-functional teams in resolving validation issues.
  • Equipment Qualification: Experience in equipment qualification, including analytical instrumentation and manufacturing equipment.
  • Industry Expertise: Work experience in Pharmaceutical or BioPharma industries.
  • Hands-on Execution: Proven hands-on validation execution experience.
  • Cleanroom Environment: Ability to execute activities in cGMP environments, including cleanrooms or technical areas.

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