{"id":3477464,"url":"https://alion.io/job/fujifilm-senior-engineer-12-cqv-upstream-downstream","title":"Senior Engineer 1/2, CQV Upstream & Downstream","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":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","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":{"min_usd":77000,"max_usd":145000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-10-29T19:16:34Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-02T16:59:18Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Position Overview\nThe Senior CQV Engineer 1 leads the commissioning and qualification of equipment and systems of assigned area for the site. This role performs and leads the CQV team through the validation lifecycle, investigation of deviations and root cause analyses, and establishes standard operating procedures and other documents. This role collaborates with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and align and comply with regulatory requirements and quality standards. Additionally, this role provides training and guidance to junior engineers to ensure successful integration of CQV activities into site projects.\nThe Senior Engineer 2, CQV serves as a subject matter expert and leads the commissioning and qualification of equipment and systems for multiple areas of the site. This role performs and leads the CQV team through the validation lifecycle, investigation of deviations and root cause analyses, and establishes standard operating procedures and other documents. This role partners with internal and external stakeholders to ensure strategies, equipment, and systems incorporate global standards and align and comply with regulatory requirements and quality standards. Additionally, this role provides training and guidance to junior engineers to ensure successful integration of CQV activities into site projects.\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\nWhat You’ll Do\nActs as CQV Technical Lead for process support equipment to establish validation strategies, develop validation procedures that align with FDB’s Large Scale Biologics platform operating principles and regulatory requirements. \nProvides guidance and leads the management of validation lifecycle for responsible areas for process support equipment and warehouse during Installation Verification (IV), Operational Verification (OV), Installation & Operational Qualification (IOQ), Performance Qualification (PQ) through Good Manufacturing Practices (GMP) release to decommissioning.\nProvides technical support and leads external validation engineers through commissioning, qualification and validation of Large-Scale Biologics facilities and equipment.\nParticipates with FUJIFILM Biotechnologies cross-network to inform and influence strategic management of validation programs, and working knowledge to incorporate global standards at the site level.\nLiaises and collaborates with key stakeholders and support groups (e.g., Manufacturing, Process Science, Automation, Supply Chain, and Quality) to ensure FDB validation requirements are met.\nCollaborates cross-functionally to ensure successful integration of CQV activities into projects.\nEstablishes Validation standard operating procedures (SOPs), Validation Project Plan (VPP), and Validation Master Plan (VMP) to ensure full cGMP compliance by operations launch.\nLiaises with CQV Document Generation Lead to generate and approve DQ, Design Reviews, SLIA, Test Matrices, Risk Assessments, QA Vendor Assessments, FAT, SAT, CTP, and IOQ Protocols. \nLeads the investigation of qualification deviations or discrepancies utilizing problem solving, and root cause analysis (RCA) to properly identify root causes and develop remediation plans (e.g., corrective and preventive action (CAPAs)).\nPerforms change control validation assessments to determine risk-based qualification, requirements for new systems, and changes to existing qualified systems.\nConducts impact and risk assessments and identifies risks and develops and leads the implementation of mitigation strategies.\nProvides guidance and training to junior engineers for all CQV-related activities, as needed.\nOther duties, as assigned.\nAdditional Senior Engineer II Responsibilities \nParticipates in the Global subject matter expert (SME) Network to ensure cross-site alignment for CQV. \nPrepares presentation packages for FDBN’s Validation Lifecycle program for internal and external audits and client visits and participates in presenting, as required. \nKnowledge, Skills, and Abilities\nEffective communication, both written and oral.\nAbility to effectively present information to others.\nProficient knowledge of Microsoft Office (e.g., Word, PowerPoint).\nKnowledge of industry guidelines International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), United States and international regulations such as Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), ISO, EU) for validation of GMP facilities. \nAdditional Senior Engineer II Skills and Abilities \nAbility to develop effective working relationships internally and externally. \nAdvanced strategic planning and problem-solving skills. \nMinimum Qualifications\nSenior Engineer I:\nBachelor’s degree in Engineering.\n8 years of experience in validation activities in facilities, commissioning, and systems qualifications.\nExperience with cGMP or working in another highly regulated industry.\nSenior Engineer II:\nBachelor’s degree in Engineering.\n12 years of experience in validation activities in facilities, commissioning, and systems qualifications. \nExperience with cGMP or working in another highly regulated industry. \nPreferred Qualifications\nSenior Engineer I:\nMaster’s degree in Engineering with 6 years of experience in validation activities in facilities, commissioning, and system qualifications.\nSenior Engineer II:\nMaster’s degree in Engineering with 8 years of experience in validation activities in facilities, commissioning, and system qualifications. \nExperience working within industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities. \nExperience with Biologics License Application (BLA) submissions etc. \nPhysical Requirements:\nThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:\nMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.\nWill work in environment operating a motor vehicle or Powered Industrial Truck.\nAbility to discern audible cues. \nAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishable color.\nAbility to ascend or descend ladders, scaffolding, ramps, etc.\nAbility to stand for prolonged periods of time for up to 240 minutes.\nAbility to sit for prolonged periods of time for up to 240 minutes.\nAbility to conduct activities using repetitive motions that include wrists, hands, and/or fingers. \nAbility to operate machinery and/or power tools.\nAbility to conduct work that includes moving objects up to 50 pounds.\nAbility to bend, push or pull, reach to retrieve materials from 18’’ to 60’’ in height, and use twisting motions.\nWill work in warm/cold environments.\nWill work in outdoor elements such as precipitation and wind.\nWill work in small and/or enclosed spaces.\nWill work in heights greater than 4 feet.\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.\n*LI-Onsite\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":9592,"description_truncated":false,"requirements":{"experience_years_min":12,"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":["Consumer Electronics","Health Care","Digital Cameras & Photography","Medical Imaging Systems"],"lifecycle":[{"event":"open","at":"2026-10-29T19:16:34Z"}],"visa":[{"country":"US","licensed_sponsor":true,"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":"2026-10-29T16:27:21+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":81,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.899,"p_room":0.9,"age_days":3,"expected_fill_days":6,"reasons":["conf:2","velocity","win:mid","comp:brand"],"computed_at":"2026-11-02T06:13:15Z"},"pay":null,"html_url":"https://alion.io/job/fujifilm-senior-engineer-12-cqv-upstream-downstream","json_url":"https://alion.io/job/fujifilm-senior-engineer-12-cqv-upstream-downstream.json","meta":{"generated_at":"2026-11-02T18:41:04Z","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":26187,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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-senior-engineer-12-cqv-upstream-downstream"},{"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-senior-engineer-12-cqv-upstream-downstream"},{"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-senior-engineer-12-cqv-upstream-downstream"},{"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-senior-engineer-12-cqv-upstream-downstream\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ffujifilm-senior-engineer-12-cqv-upstream-downstream"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3477464}},{"tool":"search_jobs","arguments":{"company":"fujifilm.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3477464},"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. Docs: https://alion.io/developers"}}