About VVMF
Viral 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 commercial manufacturing facility of its kind in Australia. Based at the Westmead Health Precinct in Westmead, NSW, VVMF are uniquely integrated in the largest health, education, research, and innovation precinct in the country. VVMF is set to become a leading Contract Development and Manufacturing Organisation (CDMO) in Asia-Pacific, producing clinical and commercial grade viral vectors for advanced therapeutic applications.
VVMF is building a values-based organisation that is committed to equality, diversity, and inclusion. They aim to deliver an outstanding product and are committed to excellence in service and experience for everyone associated with their facility.
The Opportunity The opportunity is available for an experienced Process Engineer to join the VVMF facility. Reporting directly to the Hiring Manager, you will be responsible for supporting and ensuring that all systems are validated and compliant with all regulatory bodies for the facility.
Key Responsibilities Under the guidance of the Processing Engineering Manager, the Process Engineer will have the following responsibilities:
Validation: - Execute the Validation Master Plan (VMP) in alignment with the VVMF Quality Management System (QMS) and adhere to the annual plans.
- Support the validation processes for the implementation of computerized systems, ensuring compliance with regulatory standards.
- Manage the entire lifecycle of Computer System Validations (CSV) from initiation through to release.
- Accurately document validation outcomes, conclusions, and recommendations as specified in the VMP and associated protocols.
- Assist with project activities related to the site’s capital plan.
- Maintain and update documentation on production procedures and processes.
- Monitor, support, and improve ongoing validation compliance processes.
- Conduct regular system reviews to ensure systems sustain their validated status.
- Participate in internal and external audits related to the site’s validation program as an Audit Team member or Subject Matter Expert.
- Perform risk-based analyses to minimize Out of Specification (OOS) incidents and deviations in production.
- Explore methods to monitor and control equipment and processes for increased efficiency, optimized yields, and sustained validation.
- Assist with routine tasks supporting manufacturing operations.
- Collaborate with other departments to achieve organizational goals.
Training and Development: - Develop and deliver communication, training, and mentorship on validation processes to key site personnel, including initial training and handover to the production team.
It is essential to note that the Process Engineer will conduct all manufacturing activities in accordance with VVMF SOPs and comply with all TGA, FDA, and/or EMA regulatory requirements.
This role will be required to support the Operations team as necessary with additional tasks outside of day-to-day production
About You
Required Experience: - Aseptic Technique in Cell Culture: Extensive hands-on experience in aseptic techniques within cell culture environments.
- Training Expertise: Proven ability in training individuals on new and established procedures/processes.
- Documentation Skills: Strong experience in drafting and executing documentation, including Standard Operating Procedures, Qualifications, and Validations.
- Teamwork and Independence: Demonstrated ability to work effectively both as an integral team member and independently.
- Technical Documentation: Proficient in documenting scientific and technical protocols and processes.
- Communication and Time Management: Effective, collaborative communication skills, along with excellent time management and ability to meet deadlines.
- cGMP Knowledge: Thorough understanding of current Good Manufacturing Practices (cGMP).
Desirable Experience: - CSV Activities: Over 2 years of experience conducting CSV activities in a cGMP-regulated environment (TGA, FDA, and/or EMA).
- System Implementation: Previous experience with implementing computerized systems.
- Equipment and System Management: Skills in equipment and computerized systems startup, troubleshooting, building automation, pharmaceutical manufacturing processes, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs.
- Validation Protocols: In-depth knowledge of validation protocols for equipment and systems.
- Project Management: Familiarity with project management tools and functions.
- Microsoft Office Proficiency: Competency in using Microsoft Word and Microsoft Excel.
- Regulatory Compliance: Solid understanding of 21 CFR Part 11 and Annex 15 compliance requirements.
Required Qualifications: - Tertiary qualification in Chemical Engineering or a related science or engineering discipline.
To be considered for this current opportunity, or any other opportunities within the Viral Vector Manufacturing Facility (VVMF) VVMF, please send your CV to our regularly attended dedicated VVMF careers inbox:
vvmfcareers@keselect.com. For any confidential discussion, please contact Yash (0401 271 481)
KE Select is an Australian-based, leading Scientific & Medical Recruitment Partner for many organisations within the Life Science, Medical, Clinical, Hospital and Healthcare space. If you are a candidate looking for a new role or a company looking for an industry-specific recruitment firm, please visit our website to find out more: www.keselect.com
