{"id":1010747,"url":"https://alion.io/job/genezen-sr-processvalidation-engineer","title":"Sr. Process/Validation Engineer","company":{"id":719970,"name":"Genezen","domain":"genezen.com","url":"https://alion.io/company/genezen","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":83,"open_postings":3,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":46,"computed_at":"2026-11-03T05:54:40Z"}},"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":"explicit","locations":["Indianapolis, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":80000,"max_usd":151000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"experience_years_min":5,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"AutoCAD","optional":false},{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-17T15:15:50Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-11-03T11:25:03Z","board_verified":true,"closed_at":null,"days_open":46,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":46},"description":"The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. \nWORKING AT GENEZEN\nMany people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.\nJOB SUMMARY\nThe Sr. Process/Validation Engineerplays a key role supporting operations atGenezen’sgene therapy facility and will provide operational support to all groups including MFG, FAC, QC, SC,MSATand PD. The incumbent will provide a variety of support services including equipment performance evaluation, troubleshooting, procedure development, process and equipment monitoring, validation / qualification, CI’sand leadership of medium to large projects. \nESSENTIAL JOB FUNCTIONS\n Prepare, schedule, coordinate and monitor their assigned engineering projects \nManage projects associated with workflow optimization, mistake-proofing, and continuous improvement. \nSupports change management processes to achieve desired business outcomes in a complex business environment. \nMonitor compliance to all applicable FDA and EU practices, QA/QC policies, performance standards and specifications. \nInteract daily with internal team members and external third parties to interpret their needs and requirements and represent them in the field. \nPerform overall quality control of their work (budget, schedule, plans, personnel performance) and report regularly on project and maintenance/calibration status. \nCooperate and communicate effectively with team members, other project participants, and upper management to assist with technical support. \nBe seen as technical engineering expert and be responsible for daily operations team huddle and daily site standup meeting providing updates on equipment, qualification status, documentation, and any CAPA’s or deviations. \nTroubleshoot equipment and systems issues and develop solutions. \nEnsure internal and external team members/contractors maintain the highest quality standards. \nIdentifying deficiencies in MEP processes and developing improvements. \nDeveloping, initiating, and managing all phases of projects, maintenance/calibration. \nPreparing documentation of critical analysis and providing suggestions for correcting errors across projects and maintenance/calibration. \nSPECIAL WORK REQUIREMENTS\nAdaptability required as work schedule may change based on business needs\nCriminal background check required\nOther duties as assigned\n\nKNOWLEDGE, SKILLS AND EXPERIENCE\nEDUCATION/CERTIFCATIONS/LICENSES\n\nBS/BA degree in Engineering, Science, Technical or related field \nEssential \n\nPharmaceutical, Biomedical, or Medical Device experience \n\nEssential \n\nON-THE-JOB EXPERIENCE\n\n5+ years of engineering/project management experience \n\nEssential\n\nProven working experience as an Engineer, Project Manager with experience in CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization\n\nEssential\n\nAdherence to all local, state, and governmental safety standards\n\nEssential\n\nExcellent knowledge of design and visualization software such as AutoCAD\n\nEssential\n\nFamiliarity with rules, regulations, best practices, and performance standards\n\nEssential\n\nSKILLS/ABILITIES\n\nAdvanced MS Office skills\n\nEssential\n\nProject management and supervision skills\n\nEssential\n\nDecision making ability and leadership skills\n\nEssential\n\nTime management and organization skills\n\nEssential\n\nAbility to work with multiple discipline projects\n\nEssential\n\nWork Environment\nFrequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning\nRegularly required to work around large machinery and typical utilities seen in pharmaceutical facilities\nOccasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock\nOccasionally exposed to extremely loud noise levels\nSpending time on the floor during activity execution (maintenance, construction, commissioning, and qualification) is required\nMovement\nFrequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms \nOccasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl\nLifting\nFrequently lift and/or move up to 10 pounds\nOccasionally lift and/or move up to 25 pounds\nVision\nFrequently utilize close vision and the ability to adjust focus\nCommunication\nFrequently required to communicate by talking, hearing, using telephone and e-mail\nGENEZEN'S CURESVALUE-BASED COMPETENCIES\nCommitted to Science\nWe are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.\nUrgency in action for the patients\nWe operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.\nResilience & Grit in operations\nWe are committed to overcoming challenges, learning from failures, and persistently striving for success. \nExecute with Excellence & Integrity\nWe are dedicated to delivering quality results and upholding ethical principals.\nSolutions driven for our partners\nWe are committed to being a proactive, collaborative, creative and open-minded partner.\nGENEZEN'S BENEFITS\nPaid vacation days, amount based on tenure\nPaid sick time\n10 observed holidays + 2 floating holiday + 1 volunteer day\n401(k) plan with company match up to 6% of salary\nShare Appreciation Rights\nChoice of several healthcare plans\nFSA and HSA programs\nDental & vision care\nEmployer-paid basic term life/personal accident insurance\nVoluntary disability, universal life/personal accident insurance\nAccidental Death & Dismemberment (AD&D) Insurance\nADDITIONAL DETAILS\nNothing in the job description for this role restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\nThis position requires a criminal background check.\nGenezen is an Equal Opportunity Employer.\nGenezen participates in EVerify.\nGenezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.\nGenezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. \nFishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world’s largest children’s museum--to name just a few reasons why this area is a great place to live.\nLexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.","description_format":"text","description_chars":7713,"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":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-09-17T19:46:51Z"}],"visa":[],"liveness":{"score":43,"band":"fade","label":"Fading","p_open":1,"p_active":0.775,"p_room":0.55,"age_days":46,"expected_fill_days":46,"reasons":["conf:3","win:tail"],"computed_at":"2026-11-03T05:54:40Z"},"pay":null,"html_url":"https://alion.io/job/genezen-sr-processvalidation-engineer","json_url":"https://alion.io/job/genezen-sr-processvalidation-engineer.json","meta":{"generated_at":"2026-11-03T13:12:34Z","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":18226,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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":719970},"rest":"https://alion.io/mcp/rest/get_company?id=719970"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgenezen-sr-processvalidation-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%2Fgenezen-sr-processvalidation-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%2Fgenezen-sr-processvalidation-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/genezen-sr-processvalidation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgenezen-sr-processvalidation-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":1010747}},{"tool":"search_jobs","arguments":{"company":"genezen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":1010747},"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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