{"id":2446220,"url":"https://alion.io/job/sanofi-plant-process-commissioning-qualification-engineer","title":"Plant Process Commissioning Qualification Engineer","company":{"id":146,"name":"Sanofi","domain":"sanofi.com","url":"https://alion.io/company/sanofi","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":98,"open_postings":75,"ghost_share":0,"stale_share":0.227,"repost_share":0.093,"time_to_fill_p50_days":21,"computed_at":"2026-10-24T06:02:35Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Swiftwater, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":85500,"max":123500,"currency":"USD","period":"year","gross":null,"usd_annual":123500},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Chromatography","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-13T13:34:56Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-24T10:04:28Z","board_verified":true,"closed_at":null,"days_open":11,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":11},"description":"Job Title: Plant Process Commissioning Qualification Engineer\nLocation: Swiftwater, PA\nAbout the Job\nThe Plant Process Commissioning Qualification Engineer is a critical engineering quality review and execution support role responsible for the consistent application governance and maintenance of Commissioning and Qualification Engineering platform procedures In this role you will apply Commissioning and Qualification testing templates engineering standards and specifications across both OPEX and CAPEX projects You will directly support antigen and filling manufacturing operations with a strong emphasis on Inspection and Packaging processes work that ultimately protects patients and ensures the integrity of life saving vaccines and pharmaceutical products.\nJoin a global network that powers how Sanofi delivers - seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.\nAbout Sanofi:\nWe’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve lives.\nMain Responsibilities\nReview and approval of SAT FAT Commissioning and Qualification and Design documentation protocols test scripts reports assessments.\nImpact assessments Change Control Functional Component and Design Review Design Qualification DRDQ.\nProtocol and Test Script authoring.\nContinuous improvement authoring updates to site Commissioning and Qualification platform procedures\nEngineering Change Management process\nContractor management\nThis role offers a dynamic blend of technical leadership quality governance and cross functional collaboration.\nAs a key member of our engineering team, you will\nServe as the primary Commissioning and Qualification Engineering interface with project management and project controls functions supporting contractor budget and schedule performance measurements and reporting Provide strong Commissioning and Qualification focus and oversight for packaging and inspection systems.\nProvide Commissioning and Qualification support for projects focusing equipment and utilities to support Drug substance processing Final Filling process and Inspection and Packaging\nReview and approve protocols test scripts data packs and reports to ensure consistent high-quality engineering documentation across all assigned projects.\nAudit engineering quality in accordance with site and project level Commissioning and Qualification plans development qualification Global Engineering Guidelines and Quality Operational Qualification Guidelines. Update and approve site Commissioning and Qualification platform methods and procedures ensuring alignment with project lessons learned GEG updates and global quality document revisions.\nSupport technical engineering staff in the use and documentation of the engineering change management process.\nExecute audit initiatives and remediation activities including action items resulting from internal and external audits change controls and deviation remediation as directed by the Plant Process and Commissioning and Qualification Lead and or Site Project Engineering Lead\nManage contract associates as required to support Commissioning and Qualification activities.\nScope and Impact\nYour work will directly influence the quality and compliance of engineering documentation across both CAPEX and OPEX projects by applying Global Engineering Guidelines and local engineering methods you will ensure that every project meets the highest standards of engineering and regulatory excellence Specific activities include\nExecuting System and Functional Component Criticality Assessments\nConducting Design Review and Qualification activities\nAuthoring Protocols Test Scripts and Reports as assigned\nAuthoring technical assessments in support of change controls deviations and CAPA\nAbout You\nBasic qualifications\nBachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Biotechnology, Computer sciences or other related technical fields.\n5+ years of experience in Commissioning, Qualification, Testing Equipment, quality assurance, Engineering, Packaging or other related fields. \nAdditional skills:\nPackaging and Inspection process systems\nProcess Equipment Filling systems isolators purification systems\nChromatography systems autoclaves washers and Controlled Temperature Units\nGMP Utilities WFI Clean Steam Clean Compressed Air\nExperience in the vaccine or pharmaceutical industry\nDemonstrated expertise in the quality review of good documentation practices\nGDP Knowledge of quality and regulatory requirements applicable to pharmaceutical and biotech manufacturing\nExperience with contemporary commissioning and qualification methods\nWhy choose us?\n Bring the miracles of science to life alongside a supportive, future-focused team. \nDiscover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. \nEnjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. \nTake good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.\nShape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.\nPower industry-leading performance by leveraging digital, data, and AI-driven innovation - at speed and scale\nTransform lives worldwide by delivering life-changing treatments anywhere, anytime.\nSanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.\n#GD-SP \n#LI-SP\nPursue progress, discover extraordinary\nBetter is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.\nSanofi US endeavours to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please call 1-866-SANOFI2 (1-866-726-6342) or click here\nUS and Puerto Rico Residents Only\nSanofi Inc. and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.\nNorth America Applicants Only\nThe salary range for this position is:\n$85.500,00 - $123.500,00All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.","description_format":"text","description_chars":8102,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Parental leave","Wellness"],"hiring_locations":[{"name":"Puerto Rico","iso":"PR","kind":"country"},{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Vaccines","Rare Disease Therapeutics","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-13T13:34:56Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 62","filings_12m":62,"filings_prev_12m":36,"green_card_filings_12m":0,"median_offered_wage_usd":127500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":80,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.886,"p_room":0.9,"age_days":10,"expected_fill_days":21,"reasons":["conf:0","velocity","win:mid","comp:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":{"stated_usd_annual":123500,"is_top_pay":false},"html_url":"https://alion.io/job/sanofi-plant-process-commissioning-qualification-engineer","json_url":"https://alion.io/job/sanofi-plant-process-commissioning-qualification-engineer.json","meta":{"generated_at":"2026-10-24T18:32:16Z","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":26977,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"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":146},"rest":"https://alion.io/mcp/rest/get_company?id=146"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsanofi-plant-process-commissioning-qualification-engineer"},{"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%2Fsanofi-plant-process-commissioning-qualification-engineer"},{"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%2Fsanofi-plant-process-commissioning-qualification-engineer"},{"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/sanofi-plant-process-commissioning-qualification-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsanofi-plant-process-commissioning-qualification-engineer"}]}