The Company and OpportunityViral Vector Manufacturing Facility (VVMF) has exclusively partnered with KE Select Scientific & Medical Recruitment Specialists to support their recruitment strategy and growth.
VVMF is the first and only commercial manufacturing facility of its kind in Australia, uniquely integrated in the largest health, education, research, and innovation precinct in the country. Supported by a world-class clinical trial ecosystem, VVMF will in partnership design, develop and manufacture viral vector solutions for companies, customers and patients.
VVMF is a new ‘for-profit’ biotech Contract Development and Manufacturing Organisation (CDMO) that will take over operation of the existing ‘Stage 1’ pilot facility within the Sydney Children’s Health Network (SCHN) at Westmead and will commission and operate the ‘Stage 2’ commercial-scale manufacturing capability.
Stage 1 is a pilot facility with a 25-litre capacity. Already operational, the pilot facility has successfully demonstrated capability in the manufacture of non-clinical grade viral vectors and created the opportunity to expand capability and capacity to be a commercially viable biotechnical manufacturing organisation. The facility is in the process of obtaining Good Manufacturing Practice (GMP) licence from the Therapeutic Goods Administration (TGA).
Stage 2 development is well underway, having completed the design, secured statutory planning approval, selected manufacturing equipment and awarded a construction contract. Construction is due for completion end Q1 2025. The Stage 2 facility will have a 550-litre capacity and will further build capability while achieving financial sustainability by capturing the burgeoning national and international market for viral vectors. The commercial-scale facility will attract further skilled staff and supply a larger and more varied customer base.
In preparation and lead up to facility completion, VVMF are looking for two Validation Engineers to join the team. These positions are full time, 12-month max term contracts. The Validation Engineers 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. Additionally, the Validation Engineer is required to support the Operations team as necessary with associated tasks in the Stage 1 facility
Key Responsibilities· Managing implementation of the Validation Master Plan
· Executing Cytiva process development activities for the Stage 2 facility
· Monitoring Validation Reporting and validation compliance
· Reviewing and implementing production procedures and processes
· Undertake periodic system reviews
· Support development of the Preventative Maintenance plan, including costings
· Continuous improvement activities focused on efficiency, yields and compliance
· Training of 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 all aspects of facility and equipment management (ideally pharmaceutical), such as FAT/SAT verification, URS documentation, and familiarity with stages of the validation process (IQ/OQ/PQ).
· Ability 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
To ApplyIf you meet the above criteria and are interested in this opportunity, please apply online in the first instance. Alternatively, you can contact Harrison Pitts on
harrison@keselect.com or ring
0411 919 930 for a confidential discussion.
KE Select is one of Australia's leading Life Science & Medical Technology recruitment firms. KE Select have established reach throughout ANZ, Asia and the UK and 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.
