{"id":3879107,"url":"https://alion.io/job/fujifilm-engineer-2-msat","title":"Engineer 2, MSAT","company":{"id":9349,"name":"Fujifilm","domain":"fujifilm.com","url":"https://alion.io/company/fujifilm-holdings","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":{"grade":"A","score":100,"open_postings":4,"ghost_share":0,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":10,"computed_at":"2026-11-08T05:47:12Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Holly Springs, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"21 CFR Part 11","optional":true},{"name":"GLP","optional":true},{"name":"GMP","optional":true}],"status":"live","first_seen_at":"2026-11-06T17:35:28Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-08T07:55:03Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Position Overview\nJoin a mission-driven team ensuring that every batch is safe, consistent, and inspection-ready. As an Engineer/Scientist 2 on our Process Validation team, you’ll help design, execute, and document robust validation strategies-partnering across Tech Transfer, Manufacturing, Quality, and Engineering to keep processes reproducible under normal operating conditions.\nCompany Overview\nFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.\nWe’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive-what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!\nHolly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.\nFujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers\nJob Description\nAbout Us\nWe are a science-led biomanufacturing organization committed to patient safety, product quality, and operational excellence. We:\nChampion data-driven, risk-based decision-making and continuous improvement\nFoster an inclusive, respectful culture where diverse perspectives strengthen outcomes\nCollaborate closely across functions to enable reliable commercial and clinical supply\nInvest in learning, mentorship, and professional development\nResponsibilities\nSupport the team with process validation requirements across equipment, systems, and manufacturing processes\nEnsure regulatory compliance; assess change notifications related to process validation\nContribute to process validation strategy and execute all aspects of validation, including:Process Performance Qualification (PPQ) runs\nContinued Process Verification (CPV)\nOther validation studies, as needed\n\nCollaborate with Validation/CQV to support Performance Qualification (PQ) execution and at-scale assessments (e.g., worst-case soiling for cleaning validation, microbial hold, mixing validation)\nSupport process sub-teams throughout Technology Transfer (TT) phases\nFacilitate generation of sampling plans for Process Validation Reports (PVRs) and investigations\nWrite and review documentation (e.g., validation campaign summaries, PPQ protocols and reports, impact assessments) for internal and external audiences\nContribute to developing and implementing training for manufacturing staff on process validation requirements\nSupport troubleshooting, process impact assessments, Root Cause Analysis (RCA), and Corrective and Preventive Actions (CAPA) in response to critical deviations, as needed\nSupport TT stage-gate reviews for manufacturing readiness (e.g., process characterization and validation, risk assessments and mitigation, robust supporting data for proposed changes)\nSupport creation of master plans, viral segregation risk assessments, process risk assessments, contamination control strategy, and extractables/leachables assessments; contribute to relevant site procedures and policies\nParticipate in continuous improvement initiatives with Manufacturing, Quality, Engineering, and Global teams (as applicable) to improve manufacturability, reliability, yield, and cost\nCollaborate with Manufacturing to support commercial and clinical campaigns, including on-floor support\nPerform other duties, as assigned\nMinimum Qualifications\nBachelor’s degree in Engineering, Life Science, or Chemical Engineering with 2 years of relevant industry experience; or\nMaster’s degree in Engineering, Life Science, or Chemical Engineering with no previous experience\nPreferred Qualifications\nExperience using Quality Systems (e.g., deviation management system, change control, CAPA, document management system)\nExperience using risk management and RCA tools\nExperience working in a Good Manufacturing Practices (GMP) environment\nPrior drug substance manufacturing experience, including process validation\nKnowledge, Skills, and Abilities\nKnowledge of regulatory audits and inspections and requirements (e.g., FDA 21 CFR Part 11)\nUnderstanding of GMP, GLP, and GDP requirements\nKnowledge of validation principles and techniques (IQ, OQ, PQ)\nStrong problem-solving and project management skills\nExcellent communication and teamwork skills; ability to present information clearly and adapt style to different audiences\nAbility to provide constructive feedback to peers and leaders\nTo all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.\nEEO Information\nFujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.\nADA Information\nIf you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ().","description_format":"text","description_chars":6171,"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":[]},"benefits":["Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Advanced Materials","Vaccines","CRO & CDMO Services","Printers & Scanners"],"lifecycle":[{"event":"open","at":"2026-11-06T17:35:28Z"}],"visa":[{"country":"US","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"H-1B filings in 12 months: 1 · green card filings: 1","filings_12m":1,"filings_prev_12m":1,"green_card_filings_12m":1,"median_offered_wage_usd":122500,"route":null,"cap_exempt":false,"checked_at":"2026-11-07T07:57:00+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":1,"expected_fill_days":10,"reasons":["conf:1","velocity","win:early","comp:brand"],"computed_at":"2026-11-08T05:47:12Z"},"pay":null,"html_url":"https://alion.io/job/fujifilm-engineer-2-msat","json_url":"https://alion.io/job/fujifilm-engineer-2-msat.json","meta":{"generated_at":"2026-11-08T09:17:23Z","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_verified","counted_by":"address","units_charged":1,"used_today":20183,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-09T00:00:00Z"}},"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":9349},"rest":"https://alion.io/mcp/rest/get_company?id=9349"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ffujifilm-engineer-2-msat"},{"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%2Ffujifilm-engineer-2-msat"},{"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%2Ffujifilm-engineer-2-msat"},{"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/fujifilm-engineer-2-msat\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ffujifilm-engineer-2-msat"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3879107}},{"tool":"search_jobs","arguments":{"company":"fujifilm.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3879107},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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