{"id":2679151,"url":"https://alion.io/job/csl-limited-computerized-system-validation-csv-site-lead","title":"Computerized System Validation (CSV) Site Lead","company":{"id":723138,"name":"CSL Limited","domain":"csl.com","url":"https://alion.io/company/csl-5","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":80,"open_postings":32,"ghost_share":0,"stale_share":0.813,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-10-16T05:45:00Z"}},"role":"HR","role_family":"HR","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Broadmeadows, Australia"],"countries":["AU"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-16T06:06:48Z","employer_posted_date":"2026-10-16","last_verified_at":"2026-10-16T16:41:58Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.\nWe are recruiting a Computerized System Validation (CSV) Site Lead to join our team at our manufacturing facility at 189-209 Camp Road, Broadmeadows, VIC 3047.\nJob Description\nCSL is seeking an experienced CSV Site Lead to own and govern Computerized System Validation (CSV) approach and strategy for site Operational Technology (OT) platforms supporting Manufacturing and QC Laboratories.\nThis is a senior individual contributor role with strong influence across site teams and external partners. Operating within a partner-led delivery model, the CSV Site Lead ensures OT systems remain in a validated state across their lifecycle and meet global CSV, quality, data integrity, and regulatory expectations.\nYou will act as the site CSV authority for OT Platforms, providing strategic direction, governance, and oversight across CSV planning, delivery, vendor QMS integration, and driving regulatory inspections and inspection readiness.\nThis is a Permanent full-time position.\nKey Responsibilities\nOwn and govern the site CSV strategy for OT platforms (Manufacturing and Labs), ensuring alignment with global standards and a risk-based GAMP5 approach across SOPs, templates, tools, and methodologies.\nLead CSV delivery through external partners, including planning, resourcing, prioritisation, performance oversight, and vendor/QMS governance with review and approval of key CSV deliverables.\nEnsure that the validated state of OT systems are established and maintained throughout their lifecycle, overseeing upgrades, patches, configuration changes, integrations, change control, impact assessments, deviations, and CAPAs.\nAct as the site CSV subject matter expert for OT Systems, driving and supporting regulatory inspections, internal audits, inspection readiness, and remediation activities.\nPartner cross-functionally and build site capability, collaborating with Automation, Manufacturing, QC, Quality, IT, and Global CSV teams.\nProvide coaching and training, as well as driving continuous improvement initiatives.\nQualifications & Experience\nBachelor’s degree in Engineering, Automation, Computer Science, or equivalent, with 7+ years’ CSV experience in pharmaceutical, biotech, or similarly regulated industries.\nStrong knowledge of GAMP5, Annex 11, 21 CFR Part 11, SDLC, and data integrity principles.\nHands-on experience validating OT and execution systems (e.g. PCS, MES, SCADA, Historians, and laboratory systems).\nProven ability to author, review, and approve CSV documentation (IQ/OQ/PQ) and manage vendor-based delivery models.\nDemonstrated experience supporting regulatory inspections and audit readiness, with strong stakeholder engagement, governance, and strategic capability.\nApplication Period: Applications open on 16 October and close on 16 Novemmber 2026.\nAbout CSL Behring\nCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.\nCSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.\nTo learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.\nOur Benefits\nFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.\nYou Belong at CSL\nAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.\nTo learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging\nEqual Opportunity Employer\nCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.","description_format":"text","description_chars":5032,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Vaccines","Biologics & Biosimilars"],"lifecycle":[{"event":"open","at":"2026-10-16T06:06:48Z"}],"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":29,"reasons":["conf:4","win:early","comp:brand"],"computed_at":"2026-10-16T20:55:34Z"},"pay":null,"html_url":"https://alion.io/job/csl-limited-computerized-system-validation-csv-site-lead","json_url":"https://alion.io/job/csl-limited-computerized-system-validation-csv-site-lead.json","meta":{"generated_at":"2026-10-16T20:55:34Z","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_verified","counted_by":"address","units_charged":1,"used_today":1635,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-17T00:00:00Z"}},"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":723138},"rest":"https://alion.io/mcp/rest/get_company?id=723138"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcsl-limited-computerized-system-validation-csv-site-lead"},{"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%2Fcsl-limited-computerized-system-validation-csv-site-lead"},{"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%2Fcsl-limited-computerized-system-validation-csv-site-lead"},{"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/csl-limited-computerized-system-validation-csv-site-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcsl-limited-computerized-system-validation-csv-site-lead"}]}