Process Validation Engineer

Who we are

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 as well as multiple emerging indications, and impacted the lives of over 70,000 patients globally.

With a footprint in 46 countries and 300+ staff across a range of locations, PolyNovo continues to grow, and opportunity awaits.

Learn more about PolyNovo by visiting our Website or our LinkedIn page.

About The Role

PolyNovo is currently searching for a Process Validation Engineer to join the Manufacturing team. Reporting to the Validation Engineering Manager, Process Validation Engineer will be responsible for assisting the Senior Process Validation Engineer in implementing facility, equipment, and process validation, from Factory Acceptance Test through Process Validation for existing NovoSorb BTM product line and PolyNovo's new commercial line. 

Key Responsibilities

Author validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing facility, equipment, and processes.

Assist in the creation of Standard Operating Procedures (SOPs) and training materials

Assist in the implementation of quality assurance protocols for each phase of the manufacturing process including design qualification, installation qualification, operational qualification, performance qualification and Process Validation (DQ, IQ, OQ, PQ and PV) to ensure compliance with ISO 9001 / ISO 13485, 21 CFR 210 & 211 and 21CFR 820.

Support Factory Acceptance Test (FAT) and Site Acceptance Testing (SAT) for new equipment.

Draft Change Control and Document Control forms.

Assist with Process Validation data analysis.

Assist with Process Improvements.

Assist in drafting and revising engineering drawings.

Assist in maintaining all Validations by reviewing periodically according to the approved schedule and updating them, if required.

Qualifications and Experience

Engineering degree in a relevant discipline (Electrical, mechanical, manufacturing) preferably backed by specialist training in validation engineering

Work experience of 2-3 years in a process validation engineering role.

Experience working with medical grade polymers and foam an advantage

Excellent written and verbal communications, able to influence others in considering your viewpoint in meeting requirements.

Strong interpersonal skills and demonstrated ability to establish and maintain effective working relationship with co-workers, suppliers and other stakeholders.

Proven ability to take accountability for the output, quality, accuracy and timeliness of their work

Demonstrate high personal and professional standards

Capacity to multi-task and balance competing priorities, sometimes outside of core responsibilities

Demonstrated proactive problem-solving skills

Demonstrated ability to maintain a high level of data analysis, reporting, documentation and organization.

Results focused

Why PolyNovo?

Join a team that values innovation, collaboration, and professional growth. At PolyNovo, we offer a dynamic work environment and the opportunity to contribute to ground-breaking projects that shape the future of our company and the industry.

Multinational, ASX 300 listed and values-led business dedicated to redefining healing for the benefit of our patients

Unique platform technology, an exciting pipeline of highly innovative products

Diverse, inclusive and flexible workplace culture

Career development opportunities and unlimited access to online learning

Rewards platform with access to discounts at over 450+ Australian retailers

Paid parental leave for primary and secondary carers, Nurture Days, and more

Salary packaging including novated car leasing.

Apply Today

Please send your resume by clicking on the Apply button. Please note that, due to the high level of interest expected, only shortlisted candidates will be contacted. 

Please note only applicants with full working rights in Australia will be considered.

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.

Learn more about PolyNovo at: https://au.polynovo.com/company/