{"id":2353526,"url":"https://alion.io/job/northway-biotech-validation-engineer","title":"Validation Engineer","company":{"id":2256897,"name":"Northway Biotech","domain":"northwaybiotech.com","url":"https://alion.io/company/northwaybiotech","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Teamtailor","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Vilnius, Lithuania"],"countries":["LT"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":33000,"max_usd":73000,"period":"year","method":"role_country_seniority_unknown","sample_n":57},"experience_years_min":null,"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":"2026-07-30T14:20:59Z","employer_posted_date":"2026-07-30","last_verified_at":"2026-10-29T16:34:00Z","board_verified":true,"closed_at":null,"days_open":91,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":91},"description":"Position description\nExecute and support qualification and validation activities including:\nIQ/OQ/PQ protocols\n\nCleaning validation\n\nComputer system validation (CSV)\n\nUtility and facility qualification\n\nPrepare, review, and approve validation documentation, protocols, reports, risk assessments, and deviations.\n\nCoordinate validation activities with internal departments and external vendors.\n\nSupport commissioning and startup of new manufacturing equipment and systems.\n\nEnsure compliance with GMP requirements and company quality standards.\n\nParticipate in change control, CAPA, and deviation investigations related to validated systems.\n\nMaintain validation master plans and lifecycle documentation.\n\nAssist during regulatory inspections and customer audits.\n\nDrive continuous improvement initiatives within validation and engineering processes.\n\nExpectations for the new colleague\nBachelor’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related technical field.\n\nStrong technical writing and documentation skills.\n\nAbility to manage multiple projects and work independently.\n\nExcellent communication and teamwork skills.\n\nExperience with GMP validation in a regulated industry (advantage).\n\nKnowledge of FDA, EMA, EU GMP, ISPE, and GAMP guidelines (advantage).\n\nFamiliarity with biologics manufacturing processes and cleanroom operations is preferred.\n\nExperience in biologics CDMO or sterile manufacturing environments.\n\nExperience with single-use systems and upstream/downstream processing equipment.\n\nUnderstanding of data integrity and Annex 11 / 21 CFR Part 11 requirements (advantage).\n\nProficiency in English and Lithuanian.\n\nCompany offers\nCompetitive salary. 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