Manufacturing Validation Specialist

1 day ago

Sydney, New South Wales, Australia KE Select Full time
About the Opportunity

Viral Vector Manufacturing Facility (VVMF) has partnered with KE Select to support their recruitment strategy and growth. VVMF is a commercial manufacturing facility of its kind in Australia, integrated in a large health, education, research, and innovation precinct.

This new 'for-profit' biotech Contract Development and Manufacturing Organisation (CDMO) will take over operation of the existing pilot facility within the Sydney Children's Health Network at Westmead and commission and operate the commercial-scale manufacturing capability.

The pilot facility has demonstrated capability in non-clinical grade viral vectors manufacture and expanded opportunity for commercially viable biotechnical manufacturing organisation. The facility is obtaining Good Manufacturing Practice (GMP) licence from the Therapeutic Goods Administration (TGA).

Job Description
  • Validate newly constructed Stage 2 viral vector manufacturing systems ensuring appropriate product quality and compliance to all TGA, FDA, and/or EMA regulatory requirements.
  • Support Operations team with associated tasks in the Stage 1 facility.
Key Responsibilities
  • Implement Validation Master Plan.
  • Execute Cytiva process development activities for the Stage 2 facility.
  • Monitor validation reporting and compliance.
  • Review and implement production procedures and processes.
  • Undertake periodic system reviews.
  • Sustain Preventative Maintenance plan, including costings.
  • Promote continuous improvement activities focused on efficiency, yields, and compliance.
  • Train production team and other key site personnel for handover.
Requirements
  • Hold a relevant degree in Chemical Engineering or related Science/Engineering discipline.
  • Demonstrated experience in commissioning and/or qualification activities in a cGMP regulated facility.
  • Greenfield experience supporting scale up of manufacturing.
  • Experience in facility and equipment management, such as FAT/SAT verification, URS documentation, and familiarity with stages of the validation process (IQ/OQ/PQ).
  • Able to understand P&IDs and strong knowledge of building automation processes.
  • Confidence in project management tools and methodologies.
  • Strong communication skills.
  • Alignment with VVMF values.
Estimated Salary Range

$80,000 - $110,000 per annum, depending on qualifications and experience.

KE Select is one of Australia's leading Life Science & Medical Technology recruitment firms, established with a market presence exceeding ten years. KE Select is quickly becoming the recruiter of choice for many organisations within the Pathology, Life Science, Medical Device and Clinical space.

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