Get AI-powered advice on this job and more exclusive features.Who we arePolyNovo is an Australian multinational medical device company that designs, develops, and manufactures truly innovative dermal regeneration solutions, including NovoSorb Biodegradable Temporising Matrix (BTM), using our patented NovoSorb resorbable, fully biodegradable polymer technology.In the last five years, PolyNovo has grown from 40 staff to more than 265 globally and has now touched the lives of over 50,000 patients. Our lifesaving and life-changing products have revolutionised the treatment of burns and major trauma, as well as multiple emerging indications and there is nothing but blue skies ahead with a diverse range of medical device products in the pipeline.With TGA, FDA, CE Mark/ MDR, Health Canada, and other registrations, our world-best polymer devices are enhancing clinical outcomes for patients around the world. See www.polynovo.com for more.About The RolePolyNovo 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 manufacturing.ResponsibilitiesUnderstand the development of CSV and equipment specifications and executing Computer System Validation, System Development 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 documents.Author validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing facilities, equipment, and processes.Assist in the creation of Standard Operating Procedures (SOPs) and training materials.Provide peer reviews on specifications, protocols and reports.To ensure the quality of PolyNovo's software applications and equipment by validating/qualifying to specifications. Provide comprehensive documentation (specifications and validation/qualifications) to meet ISO 13485 and FDA regulations.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 signatures.Draft Change Control and Document Control forms.Assist with Process Improvements.Assist in maintaining all Validations by reviewing periodically according to the approved schedule and updating them, if required.Other ResponsibilitiesEnsure collaborative relationships with PolyNovo team members and external stakeholders.Ensure all documentation is reviewed, current and quality system compliant.Comply with all company quality standards, procedures, and workplace health and safety requirements.Operate within the requirements of the quality system and ensure responsibilities are carried out in accordance with the requirements of the applicable regulatory and quality processes.About YouEngineering degree in a relevant discipline (Computer, Electrical, Software Engineering), preferably backed by specialist training in validation engineering.2 - 3 years of experience in computer system validation.Practical knowledge of 21 CFR Part 11 (electronic records/electronic signatures).In-depth knowledge of MS Office tools.Strong written and verbal communication skills, with the ability to influence others and meet requirements effectively.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 timeliness.Demonstrate high personal and professional standards.Ability to handle multiple tasks and prioritize competing responsibilities.Strong problem-solving skills with a proactive approach.Proficient in data analysis, reporting, documentation, and organizational skills.Result-driven and focused on achieving objectives.Why PolyNovoJoin 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.Work for a global, ASX-listed, values-led business dedicated to improving patient outcomes.Highly innovative products.Dynamic, multicultural, and innovative work environment.Career development opportunities and unlimited access to online learning.Hybrid and flexible working arrangements.Regular rewards and recognition, along with access to discounts with over 450 retailers.Salary packaging including novated car leasing.Apply TodayPlease send your resume by clicking on the apply button. Please note that only shortlisted candidates will be contacted.Learn more about PolyNovo at: https://au.polynovo.com/company/PLEASE NOTE ONLY APPLICANTS WITH FULL WORKING RIGHTS IN AUSTRALIA WILL BE CONSIDERED.Seniority levelMid-Senior levelEmployment typeFull-timeJob functionEngineering and ManufacturingIndustriesMedical Equipment Manufacturing
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