{"id":1426201,"url":"https://alion.io/job/thermo-fisher-scientific-engineer-ii-computer-systems-validation","title":"Engineer II, 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":77,"open_postings":306,"ghost_share":0.003,"stale_share":0.889,"repost_share":0.007,"time_to_fill_p50_days":27,"computed_at":"2026-10-26T05:57:25Z"}},"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":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-09T00:00:00Z","employer_posted_date":"2026-09-09","last_verified_at":"2026-10-24T09:29:18Z","board_verified":false,"closed_at":null,"days_open":47,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":47},"description":"Work Schedule\nStandard (Mon-Fri)Environmental Conditions\nAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description\nJob 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.\nAbout the Business\nJoin our Pharma Services Group (PSG)-a global leader providing integrated drug development and manufacturing solutions to pharmaceutical and biotech companies. Our Greenville, North Carolina site specializes in sterile and oral solid dose (OSD) manufacturing, supported by advanced technologies and a highly collaborative team environment.\nDiscover Impactful Work\nAs an Engineer II, Computer Systems Validation (CSV), you will support validation activities tied to automation systems, manufacturing equipment, and computerized systems across the site. This role is primarily focused on change management and validation of existing commercial manufacturing systems, ensuring compliance and operational readiness.\nYou will partner closely with automation, manufacturing, and quality teams to evaluate system changes, determine validation requirements, and execute qualification activities that maintain regulatory compliance and product quality.\nA Day in the Life\nEvaluate changes to existing manufacturing systems, equipment, and related databases\n\nSupport change management activities for commercial production lines\n\nAuthor and execute validation documentation including IQ/OQ/PQ protocols and qualification plans\n\nPerform risk assessments, validation assessments, and gap analyses to determine testing requirements\n\nCollaborate with automation and engineering teams to qualify system changes\n\nSupport validation of automation and control systems (PLC, SCADA, DCS, DeltaV, etc.)\n\nEnsure compliance with cGMP, FDA, and industry standards\n\nMaintain accurate and compliant validation documentation\n\nParticipate in continuous improvement and operational excellence initiatives\n\nWork Schedule & Environment\nStandard schedule: Monday-Friday, 8:00 AM - 5:00 PM\n\nFlexibility required to support off-hours work during shutdowns or system availability windows\n\nFully onsite role in Greenville, NC\n\nWork may occur in manufacturing or controlled environments as needed\n\nKeys to Success\nEducation (Required)\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\nExperience (Preferred, Not Required)\nApproximately 2 years of experience in validation, CSV, or a GMP-regulated environment\n\nInternship, co-op, or academic project experience in validation, automation, or regulated industries will also be considered\n\nKnowledge, Skills, Abilities\nFoundational understanding of cGMP and regulated environments\n\nExposure to Computer Systems Validation (CSV), CQV, or automation validation\n\nFamiliarity with automation/control systems (e.g., PLCs, SCADA, DCS, DeltaV, Allen-Bradley)\n\nAbility to support development of validation protocols (IQ/OQ/PQ)\n\nStrong technical writing and documentation skills\n\nBasic understanding of risk assessments and gap analysis\n\nStrong analytical and problem-solving skills\n\nEffective communication and collaboration skills\n\nAbility to manage multiple tasks in a fast-paced environment\n\nProficiency with Microsoft Office tools\n\nPreferred Qualifications\nExperience working with automation engineers or manufacturing systems\n\nExposure to change management processes in regulated environments\n\nFamiliarity with quality systems and validation lifecycle documentation\n\nCompetencies\nDetail-oriented\n\nCollaborative team player\n\nAdaptable and flexible\n\nStrong communicator\n\nQuality and compliance 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