Senior Validation Specialist

1 week ago

Singapore beBeeQualification Full time $100,000 - $120,000
Key Responsibilities

As a Senior Commissioning and Qualification expert, you will lead our clients in the Life Sciences sector by planning, performing, and coordinating validation activities. Your daily tasks will involve planning, execution, and coordination of computer system validation, equipment qualification, temperature-controlled objects, clean utilities validation, and cleaning validation.

We are seeking candidates with relevant experience in validation activities, including equipment qualification, analytical instrumentation, and pharmaceutical or biopharmaceutical industries. If you have hands-on validation execution experience and can execute activities in a cGMP environment, we encourage you to apply.

  • Plan, execute, and coordinate qualification activities for manufacturing equipment, analytical instruments, and temperature-controlled objects.
  • Develop, review, and approve equipment qualification and analytical instrument lifecycle documentations, including FAT, SAT, IQ, OQ, PQ protocols and reports, risk assessments, and technical specifications.
  • Lead investigations into discrepancies identified during qualification activities.
  • Collaborate with cross-functional teams to resolve validation issues.
Requirements:
  • Relevant experience in validation activities, including creation, pre-execution approval, execution, post-execution review, and post-execution approval of validation lifecycle documents.
  • Experience in equipment qualification, including analytical instrumentation and manufacturing equipment.
  • Work experience in Pharmaceutical or BioPharma industries.
  • Hands-on validation execution experience.
  • Able to execute activities in a cGMP environment, including cleanrooms or technical areas.
Preferred Skills:
  • Quality Management.
  • Quality Assurance.
  • Project Delivery.
  • Manufacturing.
  • Commissioning.
  • Analytical Instruments.
  • Team Player.
  • Life Sciences.

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