{"id":2094831,"url":"https://alion.io/job/cai-computer-systems-validation-engineer","title":"Computer Systems 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":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Boston, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":75000,"max":106000,"currency":"USD","period":"year","gross":null,"usd_annual":106000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-26T17:41:38Z","employer_posted_date":"2026-08-26","last_verified_at":"2026-10-12T20:21:51Z","board_verified":true,"closed_at":null,"days_open":47,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":46},"description":"Are You Ready?\nCAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.\nOur approach is simple-we put the client’s interests first, we don’t stop until it’s right, and we do whatever it takes to get there.\nOur Foundational Principles:\n- We act with integrity\n- We serve each other\n- We serve society\n- We work for our future\nWe work diligently to accomplish team goals and live our core values:\n- Team Before Self\n- Respect for Others\n- Can-Do Attitude\nKey Responsibilities\nDocumentation & Compliance\nAuthor GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)\nGenerate and execute test protocols and scripts\nEnsure adherence to 21 CFR Part 11 and data integrity principles\nReview and contribute to validation plans and risk assessments\nSystem & Industry Expertise\nSupport CSV activities across various platforms including MES, DCS, SCADA, and batch systems\nEngage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, Wonderware\nApply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)\nUtilize familiarity with S88/S95 batch control standards\nApply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and Rockwell\nClient Support & Technical Execution\nSupport client engagements with strong customer-service orientation\nPerform system assessments and remediation related to data integrity\nCollaborate with client teams to ensure validation compliance and delivery\nQualifications and Experience\nBachelor’s degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be accepted\nMinimum of 3+ years of experience in computer systems validation\nExperience in biotech or pharmaceutical environments preferred over medical device\nIn-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)\nFamiliarity with S88/S95 batch control standards\nExperience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferred\nExperience with multiple automation and manufacturing execution systems is highly desirable\nData integrity assessment/remediation experience is a plus\nOther Requirements\n- Excellent oral and written communication skills in English\n- Ability to travel domestically and internationally as required\n- Willingness to work paid overtime when needed\n- Must be authorized to work in the U.S. without current or future sponsorship\nCritical Competencies\nInfluence Strategy\n- Pursues opportunities based on organizational fit and strategy\n- Identifies high-impact, innovative solutions\nSatisfy the Customer\n- Anticipates and meets client needs\n- Delivers high-quality solutions and maintains satisfaction\nPlan for Success\n- Aligns business goals with execution plans\n- Allocates resources and builds risk mitigation strategies\nPursue Execution\n- Prioritizes effectively and ensures accountability\n- Proactively addresses challenges\nTailor Communication\n- Communicates clearly and professionally\n- Adapts style for technical and non-technical audiences\nBuild Partnerships\n- Builds cross-functional networks\n- Promotes collaboration and stakeholder engagement\nInfluence Others\n- Gains support through sound reasoning\n- Promotes innovation and value\nDevelop Self and Others\n- Demonstrates integrity and commitment to growth\n- Builds effective relationships internally and 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