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Commissioning Specialist

2 weeks ago

Melbourne, Victoria, Australia beBeeValidation Full time
Pharmaceutical Commissioning Qualification Validation Engineer

This position involves developing documentation to support commissioning, qualification, and validation of pharmaceutical facilities, utilities, and equipment. The successful candidate will be responsible for protocol writing and execution, field verification, and development of summary reports at client sites.

The ideal candidate will have a relevant degree or equivalent experience in the field, as well as 2-7 years' experience performing commissioning and/or qualification activities in an FDA-regulated industry. Strong technical problem-solving and troubleshooting skills are required, as well as excellent attention to detail and ability to multi-task.

Responsibilities include providing cGMP leadership and guidance for the integration and delivery of CQV services for life sciences clients. Experience in planning/directing C&Q activities is also required, as well as familiarity with Baseline Guide 5 (Second Edition).

In return for your skills and knowledge, you can expect a highly competitive salary, continuing education opportunities, and the chance to work on cutting-edge projects in a rapidly evolving field. You will also have the opportunity to collaborate with recognized subject matter experts and contribute to bringing lifesaving therapies to market.

Requirements include:

  • BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience
  • 2-7 years' experience performing commissioning and/or qualification activities in an FDA-regulated industry
  • Strong technical problem-solving and troubleshooting skills
  • Excellent attention to detail and ability to multi-task
  • Ability to work independently, while quickly building and nurturing a project team
  • Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion
  • Experience in planning/directing C&Q activities
  • Familiarity with Baseline Guide 5 (Second Edition)

Able to travel domestically if required, able to work in Australia without sponsorship. Equal opportunity employer, committed to diversity and inclusion.

Benefits include:

  • Highly competitive salary
  • Continuing education opportunities
  • Opportunities to work on cutting-edge projects in a rapidly evolving field
  • Collaboration with recognized subject matter experts

Seniority level: Mid-Senior level. Employment type: Full-time. Job function: Quality Assurance. Industry: Pharmaceutical Manufacturing.