{"id":2156797,"url":"https://alion.io/job/csiro-regulated-operation-engineer","title":"Regulated Operation Engineer","company":{"id":185,"name":"CSIRO","domain":"csiro.au","url":"https://alion.io/company/csiro","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Melbourne, Australia"],"countries":["AU"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":76000,"max":96000,"currency":"AUD","period":"year","gross":null,"usd_annual":66786},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-09T06:54:06Z","employer_posted_date":"2026-10-09","last_verified_at":"2026-10-10T21:09:52Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Acknowledgement of Country\nCSIRO acknowledges the Traditional Owners of the land, sea and waters, of the area that we live and work on across Australia. We acknowledge their continuing connection to their culture and pay our respects to their Elders past and present. View our vision towards reconciliation.\nRole highlights\nSupport operations at CSIRO’s cGMP biomanufacturing facility.\nDeliver equipment qualification, validation and facility improvements.\nHelp produce materials for early-phase clinical trials.\n\nAbout CSIRO\nAs Australia's national science agency, CSIRO is solving the greatest challenges through innovative science and technology. Many of our iconic innovations were once considered impossible until someone, just like you, joined us and took on the challenge.\nVisit CSIRO.au for more information.\nThe opportunity\nJoin CSIRO’s Regulated Biomanufacturing Group as a Regulated Operations Engineer and apply your engineering expertise in an environment where quality, reliability and scientific impact come together. You will provide hands-on engineering support within the National Vaccine and Therapeutics Laboratory, helping to maintain the safe, compliant and efficient operation of its cGMP manufacturing facility and associated quality-control laboratories.\nWorking across facility operations, equipment qualification and validation, maintenance, utilities and improvement projects, you will help troubleshoot operational issues, coordinate preventive maintenance and contribute to the installation and commissioning of new equipment and facility upgrades.\nThis is an exciting opportunity to work alongside engineers, scientists, quality specialists and project leaders, using your technical judgement and problem-solving skills to support the production of clinical trial materials and strengthen Australia’s biomanufacturing capability.\nYour high-level duties will include:\nProvide operational support for facility, plant and equipment, including troubleshooting, alarm response, repairs and preventive maintenance coordination.\nAuthor and execute commissioning, qualification and validation activities (IQ/OQ/PQ) for equipment, utilities and systems, including ongoing requalification\nSupport facility improvement projects, including new equipment installations, commissioning, upgrades, risk assessments and change controls.\nEnsure activities and documentation comply with cGMP, HSE, regulatory requirements and internal procedures, including deviations, CAPAs and safety risk assessments.\nCollaborate with Production, Quality Assurance, Quality Control, Regulated Operations, vendors and other stakeholders to support effective facility operations.\nApply technical and scientific knowledge to improve operational and validation processes and contribute to projects across multidisciplinary teams.\nMaintain a safe, clean and compliant working environment, effectively plan work to meet operational priorities, and contribute to CSIRO’s broader scientific objectives.\nRole particulars\nLocation: Clayton, Melbourne VIC\nSalary: AU$76k - AU$96k per annum + 15.4% superannuation\nTenure & work schedule: Indefinite, Full-time\nReference: 104319\nAs the successful candidate, you will bring:\nEssential\nBachelor’s degree in engineering (Mechanical, Chemical, Biomedical, or related) or equivalent relevant work experience. \nExperience working within operations, validation and/or facility management within cGMP-regulated pharmaceutical manufacturing facilities. \nExperience with facility systems (HVAC, clean utilities, EMS etc) and and/ or equipment qualification. \nAnalytical, troubleshooting, organisation, and written communication skills. \nAbility to work collaboratively across disciplines and manage competing priorities \nUnderstanding of GMP and GDP principles, and regulatory expectations (i.e. TGA). \nDesirable\nExperience with eQMS (e.g., TrackWise, Veeva, ACE). \nExperience with developing and management of SOPs. \nKnowledge of risk management tools (e.g., FMEA, HAZOP). \nExperience with process control systems/ Building management systems (Siemens, Schneider) \nExperience with CMMS (e.g. MEX) \nFor full details about this role, and other criteria, please review the Position Description.\nNot sure of you meet this criteria\nWhile it is CSIRO policy that the successful candidate must meet all the essential criteria, there are many ways to demonstrate this. Don’t let the list discourage you. If you are unsure about applying, please reach out to the contact person in the Position Description.\nSetting you up for success\nWe are committed to providing a recruitment process that is fair, equitable and accessible to everyone. We recognise that it may be helpful for us to adjust our process to make it equitable for your individual situation. Please contact Laura Mason via  and let us know how we can support you.\nLife at CSIRO and flexible work arrangements\nCSIRO offers a range of leave entitlements, benefits and career development opportunities. To find out more, visit Careers at CSIRO.\nInclusion and belonging\nSolving Australia's greatest challenges takes a diversity of minds and lived experiences. We know diverse teams are more effective and deliver more innovative outcomes. As an equal employment opportunity organisation, we are committed to creating diverse and inclusive teams where people feel they belong. We recognise true diversity encompasses all ages, abilities, cultures, faiths, levels of education, genders, sexualities, diversity of thought and much more. We focus on hiring people who share our values of People First, Further Together, Making it Real and Trusted.\nCSIRO holds Gold Status for the Australian Workplace Equality Index for LGBTQIA+ inclusion, and a Science in Australia Gender Equity Bronze Award.\nEligibility\nApplications for this position are open to Australian/New Zealand Citizens, and Australian Permanent Residents only. Appointment to this role is subject to provision of a national police check and may be subject to other security/medical/character requirements.\nChild safety\nCSIRO is committed to the safety and wellbeing of all children and young people involved in our activities and programs. View our Child Safe Policy.\nHow to apply\nPlease apply online and submit a CV and cover letter (maximum 2 pages) that demonstrate your motivation and ability to meet the selection criteria of this role.\nApplications close\n25 October 2026, 11:00pm AEDT","description_format":"text","description_chars":6445,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":["Equity","Flexible schedule"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Science & Engineering","Materials Science & Nanotechnology","Environmental Science"],"lifecycle":[{"event":"open","at":"2026-10-09T06:54:06Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":18,"reasons":["conf:3","win:early"],"computed_at":"2026-10-10T05:45:15Z"},"pay":{"stated_usd_annual":66786,"is_top_pay":false},"html_url":"https://alion.io/job/csiro-regulated-operation-engineer","json_url":"https://alion.io/job/csiro-regulated-operation-engineer.json","meta":{"generated_at":"2026-10-11T03:53:00Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":1991,"day_limit":5000,"remaining_today":3009,"minute_limit":60,"resets_at":"2026-10-12T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":185},"rest":"https://alion.io/mcp/rest/get_company?id=185"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcsiro-regulated-operation-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fcsiro-regulated-operation-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fcsiro-regulated-operation-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/csiro-regulated-operation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcsiro-regulated-operation-engineer"}]}