Validation and Commissioning Expert

2 weeks ago


Sydney, New South Wales, Australia KE Select Full time

Viral Vector Manufacturing Facility (VVMF) is a pioneering biotech Contract Development and Manufacturing Organisation (CDMO) that has partnered with KE Select Scientific & Medical Recruitment Specialists to support their recruitment strategy and growth.

With a unique integration in the largest health, education, research, and innovation precinct in Australia, VVMF will design, develop, and manufacture viral vector solutions for companies, customers, and patients.

The company operates a world-class clinical trial ecosystem and has commissioned a commercial-scale manufacturing capability at Stage 2. This facility will have a 550-litre capacity and further build capability while achieving financial sustainability by capturing the burgeoning national and international market for viral vectors.

To support this growth, VVMF is seeking two Validation Engineers to join the team on full-time, 12-month max term contracts. These professionals will be responsible for ensuring newly constructed Stage 2 viral vector manufacturing systems are validated, ensuring an appropriate level of product quality and compliance to all TGA, FDA, and/or EMA regulatory requirements.

The ideal candidate will hold a relevant degree in Chemical Engineering or a related Science/Engineering discipline and possess demonstrated experience in commissioning and/or qualification activities in a cGMP regulated facility. They should also have greenfield experience, supporting scale up of manufacturing, and familiarity with stages of the validation process (IQ/OQ/PQ).

This role requires strong knowledge of building automation processes, confidence in project management tools and methodologies, and excellent communication skills. The successful candidate will align with VVMF values and have the ability to understand P&IDs.

The estimated annual salary for this role is around $120,000 - $150,000 AUD, depending on qualifications and experience. As a key member of the Operations team, you will play a crucial role in ensuring the smooth operation of the manufacturing facility and contributing to the company's growth and success.


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