{"id":2842924,"url":"https://alion.io/job/lonza-lead-engineer-analytical-equipment-validation","title":"Lead Engineer - Analytical Equipment Validation","company":{"id":679681,"name":"Lonza","domain":"lonza.com","url":"https://alion.io/company/lonza","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":77,"open_postings":80,"ghost_share":0,"stale_share":0.938,"repost_share":0,"time_to_fill_p50_days":33,"computed_at":"2026-10-22T06:10:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Portsmouth, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":108000,"max_usd":218000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":1829},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-08-17T00:00:00Z","employer_posted_date":"2026-08-17","last_verified_at":"2026-10-22T14:37:13Z","board_verified":true,"closed_at":null,"days_open":66,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":66},"description":"Lead Engineer - Analytical Equipment Validation \nLocation: On-site, Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.\nThe focus of the Computer Systems Validation (CSV)Lead Engineer role is to identify or create industry best practices and implement these within the framework of existing GAMP regulations. Responsibilities of the CSV Lead Engineer will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP documentation revisions as well as ownership of department procedures. The position provides guidance to junior team members.\nWhat you will get:\nA collaborative and inclusive work environment.\n\nOpportunities for career growth and development.\n\nAccess to cutting-edge technologies and tools.\n\nCompetitive compensation and benefits package.\n\n401(k) matching plan.\n\nCommitment to ethical and sustainable practices.\n\nOur full list of global benefits can be found here: https://www.lonza.com/careers/benefits.\nWhat you will do:\nLead collaboration between internal teams and CSV to prioritize and complete activities on time.\n\nMaintain knowledge of Lonza policies, 21 CFR Part 11, Data Integrity, ICH Q7A, and GAMP principles.\n\nPerform QMS processes (Change Control, Deviation, CAPA) and validation maintenance of computerized systems.\n\nParticipate in audits and inspections as a Subject Matter Expert.\n\nOwn, revise and maintain CSV SOPs.\n\nSupport qualification activities and documentation for CSV validation in line with regulatory guidelines.\n\nFunction as CSV SME in inspections and Audits,\n\nWhat we are looking for:\nBachelor’s Degree is required (preferably in Computer Science/Software Engineering).\n\n5-10 years’ of Computer Systems Validation experience.\n\nExperience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation .\n\nStrong written and oral communication skills.\n\nStrong organizational and time management skills.\n\nAbout Lonza\nAt Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.\nInnovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.\nReady to shape the future of life sciences? Apply now.","description_format":"text","description_chars":2990,"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":["Relocation assistance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":true,"industries":["CRO & CDMO Services","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-19T09:48:03Z"}],"visa":[],"liveness":{"score":13,"band":"cold","label":"Long shot","p_open":1,"p_active":0.46,"p_room":0.28,"age_days":66,"expected_fill_days":33,"reasons":["conf:0","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-22T06:10:10Z"},"pay":null,"html_url":"https://alion.io/job/lonza-lead-engineer-analytical-equipment-validation","json_url":"https://alion.io/job/lonza-lead-engineer-analytical-equipment-validation.json","meta":{"generated_at":"2026-10-22T16:31:12Z","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":16833,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"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":679681},"rest":"https://alion.io/mcp/rest/get_company?id=679681"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flonza-lead-engineer-analytical-equipment-validation"},{"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%2Flonza-lead-engineer-analytical-equipment-validation"},{"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%2Flonza-lead-engineer-analytical-equipment-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/lonza-lead-engineer-analytical-equipment-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flonza-lead-engineer-analytical-equipment-validation"}]}