Computer System Validation (CSV) 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 counties, 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 Ro

lePolyNovo is seeking a skilled Computer Systems Validation Engineer to join the manufacturing team. In this role, you will be assisting the Validation Engineering Manager in implementing and validating computer systems applications, with a key emphasis on Manufacturing Execution Systems (MES), Electronic Quality Management Systems (eQMS), and Environmental Management Systems (EMS). Your responsibilities will involve ensuring strict adherence to regulatory standards governing medical device manufacturin

g.
This is a 12 month fixed term positi

on.
Responsibili

• ties
  Understand the development of CSV and equipment specifications and executing Computer System Validation, S
• ystemDevelopment Life Cycle (SDLC), and other medical equipment/system commissioning/validation (IQ/OQ/PQ) protocols in accordance with Good Engineering Practices, GAMP, local SOPs, industry best practices and other industry related guidance docum
• ents.Author validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing facilities, equipment, and proce
• sses.Assist in the creation of Standard Operating Procedures (SOPs) and training mater
• ials.Provide peer reviews on specifications, protocols and rep
• orts.To ensure the quality of PolyNovo's software applications and equipment by validating/qualifying to specificat
• ions.Provide comprehensive documentation (specifications and validation/qualifications) to meet ISO 13485 and FDA regulat
• ions.Define the development of comprehensive specifications (hardware and/or software) for equipment/software from basic functionality to complex systems such as PLCs, Visual Basic applications, databases, SCADA applications, and systems with FDA defined electronic records and electronic signat
• ures.Draft Change Control and Document Control f
• orms.Assist with Process Improvem
• ents.Assist in maintaining all Validations by reviewing periodically according to the approved schedule and updating them, if requ

ired.
Other Responsibi

• litiesEnsure collaborative relationships with PolyNovo team members and external stakeho
• lders.Ensure all documentation is reviewed, current and compliant with the quality system and all responsibilities are carried out in accordance with the requirements of the applicable regulatory and quality proc
• esses.Ensure behaviour is in line with PolyNovo V
• alues.PolyNovo may require you to undertake additional responsibilities or work in other areas than those outlined in this role, subject to business requirements and your skills and compete

ncies.
Ab

• out YouEngineering degree in a relevant discipline (Computer, Electrical, Software Engineering), preferably backed by specialist training in validation engin
• eering.2 - 3 years of experience in computer system vali
• dation.Practical knowledge of 21 CFR Part 11 (electronic records/electronic signa
• tures).In-depth knowledge of MS Offic
• e toolsStrong written and verbal communication skills, with the ability to influence others and meet requirements effec
• tively.Team-oriented with excellent interpersonal skills and a positive attitude when collaborating with various departments (Engineering, R&D, Manufacturing, Regulatory,
• etc.).Proven track record of accountability for work quality, accuracy, and time
• liness.Demonstrate high personal and professional sta
• ndards.Ability to handle multiple tasks and prioritize competing responsibi
• lities.Strong problem-solving skills with a proactive ap
• proach.Proficient in data analysis, reporting, documentation, and organizational
• skills.Result-driven and focused on achieving obje

ctives.
Why P

olyNovo?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 i

• ndustry.Multinational, ASX 200 listed and values-led business dedicated to redefining healing for the benefit of our
• patientsUnique platform technology, an exciting pipeline of highly innovative
• productsDiverse, inclusive and flexible workplace
• cultureCareer development opportunities and unlimited access to online
• learningRewards platform with access to discounts at over 450+ Australian r
• etailersPaid parental leave for primary and secondary carers, Nurture Days,
• and moreSalary packaging including novated car

leasing.
Ap

ply TodayPlease 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 c

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

onsidered.
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