Senior Validation Engineer (Bendigo)

PolyNovo is a disruptive medical technology company headquartered in Melbourne. We design, develop, and manufacture innovative dermal regeneration solutions using our patented bioabsorbable polymer technology NovoSorb®. Our lifesaving products have revolutionised the treatment of burns, major trauma, and multiple emerging indications, impacting the lives of over 70,000 patients worldwide. About the Role PolyNovo is searching for a Senior Validation Engineer to join the Manufacturing team. The role reports to the Validation Engineering Manager and involves assisting in the development, planning, and implementation of process validation in accordance with medical device manufacturing regulatory standards. Key Responsibilities
- Autonomously lead equipment process qualification and process validation projects associated with changes to existing processes/materials and new processes/materials.
- Author validation plans, protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes.
- Assist in the continuous development of risk‑based process equipment qualification and validation processes (Protocols, Procedures, Templates, etc.).
- Work closely with cross‑functional teams from the process design stage of new products and participate in the definition of process validation and control strategy.
- Provide peer reviews on user specifications, validation protocols, and reports.
- Evaluation and review of process validation data, management of change controls and deviations in projects.
- Perform process validation periodic review.
- Perform equipment qualification and validation activities in accordance with the Quality Management System, Site Validation Master Plan and Validation procedures.
- Assist in investigations of qualification and validation deviations (root cause analyses, impact analyses, CAPA definitions).
- Participate in change control panels and perform assessment of change controls for impact on facility and equipment cleaning validation status when required. Qualifications and Experience
- Degree qualification in science, biomedical/biotechnology, engineering, or another relevant discipline.
- 8‑10 years’ experience in a Validation Engineering role within medical device/pharmaceutical manufacturing or engineering organization regulated by ISO13485 and/or GMP/FDA 21 CFR 820.
- Demonstrated knowledge of GMP, ISO13485, US FDA 21CFR820 and 21CFR11. Experience in equipment qualification and process validation.
- Growth mindset and can‑do attitude.
- Valuable understanding of design control and risk management processes and their application in a manufacturing environment.
- Excellent written and verbal communication skills, able to influence others in meeting requirements.
- Capacity to work on many tasks simultaneously, sometimes outside core responsibilities.
- Intermediate to advanced proficiency in MS Word, Excel, PowerPoint.
- Self‑starter with proven ability to take accountability for quality and timeliness of work outputs.
- Strong reporting, documentation, organization skills; results oriented with data analysis and reporting.
- Ability to work flexibly, including outside normal working hours.
- Strong attention to detail and proactive problem‑solving skills. Benefits
- Multinational, ASX 300 listed and values‑led business striving to redefine healing.
- Unique platform technology with an exciting pipeline of highly innovative products.
- Diverse, inclusive and flexible workplace culture.
- Career development opportunities and unlimited online learning access.
- Rewards platform with discounts at over 450 Australian retailers.
- Paid parental leave for primary and secondary carers, Nurture Days, and more.
- Salary packaging including novated car leasing. PolyNovo is committed to creating a workplace that values equity, diversity, and inclusion. We recognise and value that it is the sum of our parts – our combined backgrounds, experiences and perspectives – that allow us to succeed. #J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3rvmxy