{"id":2243884,"url":"https://alion.io/job/one-moment-please-validation-engineer","title":"Validation Engineer","company":{"id":1821024,"name":"Bachem","domain":"bachem.com","url":"https://alion.io/company/bachem","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Vista, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":84274,"max":115877,"currency":"USD","period":"year","gross":null,"usd_annual":115877},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-08T02:00:00Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-12T18:09:16Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"A brief overview\nThe Quality Engineer (QE) / Validation fulfills a critical role in GMP operations, supporting cleaning validation activities for API and PMO manufacturing, and the qualification of equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform validation activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations\nWhat you will do\nDevelop strategy, establish acceptance criteria, generate, execute cleaning validation protocols and reports\nPerform, coordinate, execute and analyze cleaning recovery studies.\nLead cross-functional project teams to address issues and ensure on-time completion of all qualification / validation deliverables.\nProvide qualification / validation guidance and strategy during project planning and development phases.\nTrain, coach and mentor team members.\nWrite validation protocols and final reports, test methods, standard operating procedures, and technical reports.\nPlanning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and reports.\nIndependently conduct and document investigations related to validation studies.\nBased on validation studies, evaluate and make recommendations for improvements to operations, processes and methods.\nAccountable for the accuracy and validity of testing results\nSupport and assist with inspections and audits.\nPlan and perform required periodic re-validation / re-qualification activities\nWork and communicate with different associates within the company to ensure timely completion of assigned tasks and projects.\nAdherence to cGMP and safety procedures and contribute to GMP systems improvements.\nPerform other related duties as assigned.\nQualifications\nBachelor’s degree in science discipline (chemistry, biochemistry, biology or equivalent)\nMaster's degree (preferred)\n5+ years of Commissioning, Qualification & Validation (CQV) / cleaning validation experience in a GMP/GDP environment\nExperience with planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports\nExperience with validation / monitoring of critical pharmaceutical utility systems, including purified water, nitrogen systems and cold storage units\nExperience with planning and execution of cleaning validation of production lab glassware and equipment including performance of validation studies, writing validation protocols and reports and other technical documents, as well as conducting validation related investigations\nExperience with developing coupon spike and recovery studies for cleaning validation\nExperience with Lean Six Sigma methods: root cause analysis, failure mode analysis and analyzing / organizing complex technical problems\nUnderstanding of cleaning validation requirements for pharmaceutical industry\nKnowledge of and ability to perform MAC calculation for APIs\nUnderstanding of GMP for Active Pharmaceutical Ingredients per ICH Q7.\nKnowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations they undergo, including use of chemicals and their interactions, danger signs, production techniques, and disposal methods.\nMid or large-size CapEx project experience \nGeneral lab instrumentation knowledge and operation experience.\nCapable of working methodically and adhering to rules and regulations.\nBase salary range:\nEngineer II: $84,274 - $115,877\nSr Engineer: $103,939 - $142,916\nPlacement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.\nTotal Rewards\nWe offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.\nCorporate Social Responsibility\nBachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees’ environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.\nBachem Americas is an Equal Opportunity Employer\nAs an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.","description_format":"text","description_chars":4967,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-11T01:14:15Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.856,"p_room":1,"age_days":4,"expected_fill_days":26,"reasons":["conf:4","win:early"],"computed_at":"2026-10-12T06:55:09Z"},"pay":{"stated_usd_annual":115877,"is_top_pay":false},"html_url":"https://alion.io/job/one-moment-please-validation-engineer","json_url":"https://alion.io/job/one-moment-please-validation-engineer.json","meta":{"generated_at":"2026-10-12T20:47:57Z","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":33856,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-13T00:00:00Z"}},"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":1821024},"rest":"https://alion.io/mcp/rest/get_company?id=1821024"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fone-moment-please-validation-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%2Fone-moment-please-validation-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%2Fone-moment-please-validation-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/one-moment-please-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fone-moment-please-validation-engineer"}]}