{"id":1488213,"url":"https://alion.io/job/thermo-fisher-scientific-engineer-iii-computer-systems-validation","title":"Engineer III, Computer Systems Validation","company":{"id":7922,"name":"Thermo Fisher Scientific","domain":"thermofisher.com","url":"https://alion.io/company/thermo-fisher-scientific","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":78,"open_postings":299,"ghost_share":0.003,"stale_share":0.866,"repost_share":0.007,"time_to_fill_p50_days":30,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Greenville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":60000,"max_usd":110000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4330},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"closed","first_seen_at":"2026-09-29T23:55:54Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-10-27T11:45:51Z","board_verified":false,"closed_at":"2026-10-27T11:45:51Z","days_open":27,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":27},"description":"Work Schedule\nStandard (Mon-Fri)Environmental Conditions\nAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, OfficeJob Description\nAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges.\nDescription:\nJoin our validation engineering team as a Validation Engineer III (Computer Systems Validation - CSV), where you will ensure product quality and regulatory compliance across pharmaceutical manufacturing operations.\nIn this role, you will lead and execute validation activities with a strong focus on automation systems, computerized systems, and change management for existing commercial manufacturing lines. You will evaluate system and process changes, determine validation impact, and drive qualification strategies to ensure compliance with cGMP requirements.\nYou will collaborate cross-functionally with automation, manufacturing, and quality teams while serving as a technical resource during regulatory inspections and client audits. This role requires a high level of independence, technical expertise, and the ability to lead complex validation efforts.\nA Day in the Role:\nLead validation activities for equipment, processes, utilities, and computer systems, with emphasis on CSV\n\nEvaluate and support change management for existing manufacturing systems and automation platforms\n\nAuthor, review, and execute validation documentation including IQ/OQ/PQ protocols and qualification plans\n\nPerform and lead risk assessments, gap analyses, and validation assessments\n\nCollaborate with automation engineers on systems such as PLC, SCADA, DCS, DeltaV, and Allen-Bradley platforms\n\nIndependently manage validation projects and coordinate cross-functional teams\n\nProvide technical expertise during regulatory inspections and client audits\n\nMentor junior team members and support knowledge sharing across the team\n\nContribute to continuous improvement and operational excellence initiatives\n\nRequirements:\nBachelor’s degree in Engineering, Life Sciences, Chemistry, or related technical field\n\nEquivalency:\nEquivalent combinations of education, training, and relevant experience may be considered in place of a degree\nMinimum of 4 years of validation experience in pharmaceutical/biotech manufacturing or comparable regulated industry\n\nStrong knowledge of cGMP regulations (FDA, EMA, ISO)\n\nExperience with Computer Systems Validation (CSV), CQV, or automation validation\n\nExperience writing and executing IQ/OQ/PQ validation protocols\n\nExperience with automation and control systems (PLC, SCADA, DCS, DeltaV, Allen-Bradley)\n\nProven ability to lead validation projects and work cross-functionally\n\nStrong technical writing and documentation skills\n\nExperience with risk assessment methodologies and statistical analysis\n\nAdvanced problem-solving and root cause analysis skills\n\nExcellent verbal and written communication skills\n\nProficiency with MS Office and validation-related systems\n\nPreferred:\nExperience supporting or contributing to capital (CapEx) projects\n\nExperience with regulatory inspections and client audits\n\nKnowledge of lean manufacturing and continuous improvement methodologies\n\nAdditional Information:\nAbility to work in cleanroom environments as required\n\nFlexibility to support extended hours or off-shift work during project activities or shutdowns\n\nMay require up to 25% travel","description_format":"text","description_chars":3847,"description_truncated":false,"requirements":{"experience_years_min":4,"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":["Biotechnology","Health Care","Clinical Trial Services (CRO)","APIs & Drug 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