{"id":2895978,"url":"https://alion.io/job/lonza-computer-systems-validation-engineer","title":"Computer Systems Validation Engineer","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":"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":["Portsmouth, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":89000,"max_usd":169000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5966},"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":"2026-07-02T00:00:00Z","employer_posted_date":"2026-07-02","last_verified_at":"2026-10-23T05:14:24Z","board_verified":true,"closed_at":null,"days_open":113,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":112},"description":"Computer Systems Validation Engineer\nLocation: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed.\nThe Computer Systems Validation (CSV) Engineer will, as an individual contributor, identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations. During the scoping portion of these improvement projects the person in this role will work with other experienced members of the CSV team to identify roadblocks and additional efficiencies. Additional day to day tasks will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP documentation revisions.\nWhat you will get:\nCompetitive salary and comprehensive benefits package.\n\nOpportunities for career development and advancement.\n\nSupportive and collaborative team environment.\n\nAccess to cutting-edge technology and tools.\n\nCommitment to employee well-being and safety.\n\nInclusive workplace culture.\n\nRecognition and reward for your contributions.\n\nAccess to our full list of global benefits: https://www.lonza.com/careers/benefits\nWhat you will do:\nLead efforts between internal customers and CSV to ensure assigned activities are prioritized, communicated in an effective and timely manner, and completed on time.\n\nAccountable for maintaining full knowledge of Lonza's policies/procedures, 21 CFR Part 11, Data Integrity, ICH Q7A requirements and GAMP and the underlying principles of each.\n\nPerform all aspects of Quality Systems Management (QSM) processes (Change Control, Deviation, Corrective and Preventable Actions) as well as Validation Maintenance of computerized systems.\n\nParticipate in audits and inspections as a Subject Matter Expert.\n\nOwn, revise and maintain computer systems validation SOPs (Standard Operations Procedures).\n\nFunction as CSV SME in Inspections and Audits.\n\nMentor and train junior members of the department.\n\nWhat we are looking for:\nBachelor’s degree required, preferred in computer science, engineering, or other sciences.\n\nMinimum of 5 years of experience working with automation and/or computerized system validations.\n\nMinimum 2 years’ experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred.\n\nPrior experience leading or managing projects beneficial.\n\nCAPAs and deviations experience desired.\n\nBiotech/Pharma/Medical Device/Medical or biologics industry experience required.\n\nAbility to work independently and meet deadlines successfully.\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? 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