{"id":2094898,"url":"https://alion.io/job/cai-csv-engineer","title":"CSV Engineer","company":{"id":3866618,"name":"CAI","domain":"caiready.com","url":"https://alion.io/company/caiready","size_band":"501-1000","is_staffing_agency":false,"employer_type":"staffing","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Brisbane, Australia"],"countries":["AU"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":40000,"max_usd":96000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":3778},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Microsoft Project","optional":false}],"status":"live","first_seen_at":"2023-01-20T04:43:30Z","employer_posted_date":"2023-01-20","last_verified_at":"2026-10-08T22:06:59Z","board_verified":true,"closed_at":null,"days_open":1357,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1357},"description":"CAI Overview\nAre You Ready?\nCAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.\nOur approach is simple because our Purpose informs everything we do:\nWe exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.\nAt CAI, we are committed to living our Foundational Principles, both professionally and personally:\nWe act with integrity\nWe serve each other\nWe serve society\nWe work for our future\nAt CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal. It’s a way of life. Because tomorrow demands to be at the forefront of today. We do this through tireless effort, precision, efficiency and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done.\nRequirements include:\nPosition Description:\nWe are now seeking CSV Engineers to join our growing operations in Australia. The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports. Other duties may include:\nPrepares/reviews validation documentation related to projects/change controls.\nManages change controls and other compliance related tasks e.g., non-conformances.\nParticipates in the review of current and future CSV procedures and polices\nAnalyses the results of testing and determines the acceptability of results against predetermined criteria.\nInvestigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.\nIdentifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.\nCoordinates with other departments or outside contractors/vendors to complete validation tasks.\nParticipates in regulatory audits and communicates company’s computer validation policies.\nAssesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.\nManages projects and prepares status reports using Microsoft project and other communication tools.\nMay supervise, lead, or manage lower-level personnel.\nPosition Requirements: \nBS in a Computer Science or Engineering field or equivalent experience\nMinimum 2-7 years’ experience with Computer systems validation.\nMinimum 2-7 years' experience working in a GMP environment.\nExperience in Data Integrity with GAMP and 483, compliance, deep 21CFR Part 11 experience highly desired\nExperience in biotech and pharma is preferred over medical device.\nExperience with MES, Delta V, PI is a plus. We use all major systems as we serve a multitude of clients. Rockwell, GE, Emerson, ABB, Werum, Siemens, Honeywell and their associated platforms, PAS-X, Syncade, FactoryTalk, PharmaSuite, Control Logix, PLM, Simatic, iFix, Wonderware, Siemens, etc.\nOther Requirements:\nExcellent oral and written communication skills in English/Fluent in English\nAble to travel domestically and internationally as required.\nExcellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.\nHigh attention to detail.\nAbility to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.\nIndependent individual and yet a strong team player.\nIn return for your skills and knowledge, CAI offers a wide range of benefits including:\nHighly Competitive Salary\nContinuing education (internal and external)\nOpportunities to work on cutting edge projects in a highly evolving field.","description_format":"text","description_chars":4642,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Professional Services","Science & Engineering"],"lifecycle":[{"event":"open","at":"2026-10-08T16:22:48Z"}],"visa":[],"liveness":{"score":3,"band":"cold","label":"Long shot","p_open":1,"p_active":0.116,"p_room":0.28,"age_days":1357,"expected_fill_days":23,"reasons":["conf:2","win:tail","crowd:junior"],"computed_at":"2026-10-09T00:55:05Z"},"pay":null,"html_url":"https://alion.io/job/cai-csv-engineer","json_url":"https://alion.io/job/cai-csv-engineer.json","meta":{"generated_at":"2026-10-09T00:55:05Z","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":1373,"day_limit":5000,"remaining_today":3627,"minute_limit":60,"resets_at":"2026-10-10T00:00:00Z"}},"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":3866618},"rest":"https://alion.io/mcp/rest/get_company?id=3866618"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcai-csv-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%2Fcai-csv-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%2Fcai-csv-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/cai-csv-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcai-csv-engineer"}]}