{"id":4273020,"url":"https://alion.io/job/catalent-supervisor-engineering-validation","title":"Supervisor - Engineering, Validation","company":{"id":1785256,"name":"Catalent","domain":"catalent.com","url":"https://alion.io/company/catalent-com","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"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":["Madison, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Matter","optional":false}],"status":"live","first_seen_at":"2026-11-06T00:00:00Z","employer_posted_date":"2026-11-06","last_verified_at":"2026-11-13T18:24:59Z","board_verified":true,"closed_at":null,"days_open":7,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":7},"description":"About Site\nCatalent’s Madison, Wisconsin site is a state-of-the-art biologics development and manufacturing facility supporting customers from research through early- and mid-stage clinical production. Located at 726 Heartland Trail in Madison, the approximately 102,700-square-foot GMP facility specializes in mammalian cell line engineering, drug substance biomanufacturing, and biopharmaceutical development, utilizing flexible single-use systems to enable rapid scale-up and customization. The site is home to Catalent’s proprietary GPEx® and GPEx® Lightning technologies, which are used to generate high-yielding mammalian cell lines for biologic therapies, and supports production scales ranging from 50 to 4,000 liters for clinical manufacturing. Following a $45 million expansion announced in 2025, the Madison site has significantly increased capacity, added new equipment, and created approximately 200 highly skilled biohealth jobs, further strengthening its role within Catalent’s global biologics network and Wisconsin’s growing life sciences ecosystem.\nPosition Summary\nWe have an opportunity for a Supervisor - Engineering, Validation to join our team in Madison, WI. This role supports the Quality Assurance department, ensuring compliance with FDA and other regulatory requirements. The position oversees validation programs, including commissioning, qualification, and computer system validation, while maintaining systems in a validated state. The Supervisor will lead a team of validation professionals, ensuring quality, compliance, and continuous improvement across all validation activities.\nShift: M-F 8am-5pm\nLocation: Madison, WI\n100% Onsite\nThe Role\nLead a team of Validation professionals.\nMaintain Validation Master Plans.\nReview and approve validation protocols and reports.\nSupport commissioning, qualification, and validation activities.\nReview Change Controls.\nManage requalification programs.\nParticipate in audits and inspections.\nDrive continuous improvement initiatives.\nServe as Validation Subject Matter Expert (SME).\nCoordinate with Quality Assurance, Manufacturing, Facilities, Engineering, and customers.\nProvide technical training and support.\nThe Candidate\nMinimum Requirements\nDoctorate degree in a STEM field with at least 2 years of related experience, or Master’s degree in a STEM field with at least 4 years of related experience, or Bachelor’s degree in a STEM field with at least 5 years of related experience.\n0-2 years of leadership experience required.\nExperience in Commissioning, Qualification, and Validation (CQV).\nKnowledge of validation lifecycle management.\nExperience with Change Control impact assessments.\nExperience in requalification and periodic reviews.\nProficiency in validation protocol and report writing and execution.\nStrong understanding of current Good Manufacturing Practices (cGMP).\nKnowledge of FDA, ICH, and EMA regulations.\nAbility to interpret regulatory guidance and validation requirements.\nExperience leading validation projects and initiatives.\nFrequent sitting, standing, walking, computer work, and document review.\nOccasional bending, kneeling, crouching, and carrying materials.\nFrequent lifting up to 10 lbs and occasional lifting up to 50 lbs.\nAbility to work within cleanroom environments as needed.\nPreferred Skills & Background\nExperience in pharmaceutical manufacturing.\nExperience in biologics manufacturing.\nExperience in biotech manufacturing.\nExperience in cell therapy or gene therapy environments.\nExperience in Contract Development and Manufacturing Organizations (CDMOs) such as Catalent, Thermo Fisher Scientific, AbbVie, Fujifilm Diosynth, Lonza, CSL Behring, Pfizer, Amgen, Lilly, or Genentech.\nExperience supporting biologics operations involving manufacturing processes and validated systems.\nWhy You Should Join Catalent\nDefined career path and annual performance review and feedback process.\nDiverse, inclusive culture.\nPotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.\nCompetitive paid time off plus 8 paid holidays.\nCommunity engagement and green initiatives.\nMedical, dental, and vision benefits effective day one of employment.\nTuition reimbursement.\nCatalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.\npersonal initiative. dynamic pace. meaningful work.\nVisit Catalent Careers to explore career opportunities.\nCatalent is an Equal Opportunity Employer, including disability and veterans.\nIf you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.\nNotice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.\nImportant Security Notice to U.S. Job Seekers:\nCatalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to  for us to investigate with local authorities.\nCalifornia Job Seekers can find our California Job Applicant Notice HERE.\nVolunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.\nMassachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.","description_format":"text","description_chars":7221,"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":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Dietary Supplements","Contract Manufacturing","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-11-13T18:24:59Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":7,"expected_fill_days":33,"reasons":["conf:0","win:early","comp:brand"],"computed_at":"2026-11-13T19:02:18Z"},"pay":null,"html_url":"https://alion.io/job/catalent-supervisor-engineering-validation","json_url":"https://alion.io/job/catalent-supervisor-engineering-validation.json","meta":{"generated_at":"2026-11-13T19:02:18Z","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":38057,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":1785256},"rest":"https://alion.io/mcp/rest/get_company?id=1785256"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcatalent-supervisor-engineering-validation"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fcatalent-supervisor-engineering-validation"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fcatalent-supervisor-engineering-validation"},{"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/catalent-supervisor-engineering-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcatalent-supervisor-engineering-validation"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4273020}},{"tool":"search_jobs","arguments":{"company":"catalent.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4273020},"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"}}