{"id":2094901,"url":"https://alion.io/job/cai-pharmaceutical-commissioning-qualification-validation-engineer","title":"Pharmaceutical Commissioning Qualification Validation 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":{"grade":"D","score":53,"open_postings":80,"ghost_share":0.788,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-12T06:55:09Z"}},"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":["Melbourne, Australia"],"countries":["AU"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":73150,"max":115000,"currency":"AUD","period":"year","gross":null,"usd_annual":80115},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2022-08-01T08:00:07Z","employer_posted_date":"2022-08-01","last_verified_at":"2026-10-12T16:09:07Z","board_verified":true,"closed_at":null,"days_open":1533,"trust":{"level":"ghost","repost_count":0,"flags":["stale","company_stale"],"days_open":1532},"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 a CQV Engineer to join our growing operations in Australia. The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation. These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.\nThe role of a CQV Engineer in CAI is to:\nSupport documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.\nResponsible for protocol writing and execution (field verification), and development of summary reports at client sites. O\nPosition Requirements: \nBS or MS in a relevant science or engineering field, or equivalent years of hands-on experience\n2-7 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry. Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.\nProvide cGMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.\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\nAbility to work independently, while quickly building and nurturing a project team\nManaging the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.\nSupport onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns\nExperience in planning / directing C&Q activities\nProficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.\nFamiliarity with Baseline Guide 5 (Second Edition) a plus\nOther Requirements:\nExpertise in Microsoft Word and Excel\nExcellent oral and written English are required.\nAble to travel domestically if required\nAble to work in Australia without sponsorship\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":4148,"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":"All 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