{"id":3061416,"url":"https://alion.io/job/otsukaicumed-validation-engineer-ii","title":"Validation Engineer II","company":{"id":4423330,"name":"Otsukaicumed","domain":"otsukaicumed.com","url":"https://alion.io/company/otsukaicumed","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Austin, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":71000,"max_usd":130000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":4330},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-21T20:26:18Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-25T20:40:04Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Position Summary:\nThe Validation Engineer II is responsible for process knowledge of the validation section assigned to:\nEquipment\nAutomated process control systems/Computerized systems\nProcess & Cleaning\nTerminal sterilization\nFacilities & Utilities \nThe primary functions of the Validation Engineer II include the following:\nPossess process knowledge to write validation documents. \nKnowledge of validation theory and content of validation deliverables/activitiesFor Automated Systems: PLC, Controls, Robotics, Barcode Readers, Vision Systems, etc.\nFor Process and Cleaning: Technical Transfers of products\nFor Terminal Sterilization: Autoclaves, Sterilizers, Ovens\n\nExecution of validation documents to support company goals\nDevelopment of validation procedures \nSupervises reporting technicians\nActing as delegate for Sr. Validation Engineer in their absence\nEssential Duties & Responsibilities:\nDevelop Validation Plans, ensuring strategies are in alignment with validation policies, procedures and external regulatory requirements and guidance. As appropriate develop and maintain an annual plan to include periodic reviews, re-qualifications and continued process verifications to be completed during each calendar year. Reporting on progress as required.\nWrite and execute validation documents (IQ, OQ, IOQ, PQ, PV, PR, CPV, etc.) compliant with plant policies and procedures. Proactively identifying risks/issues and completing risk assessments as necessary.\nInitiate and author validation assessments and validation gap analysis as required.\nPlan and lead revalidation of existing plant equipment (including sterilization equipment), facilities, utilities, processes, control systems, software, cleaning, etc.\nReview and approve validation documentation. (Mentoring Validation Technicians as applicable)\nEnsure validation packages contain all relevant information, rationales, references, and data to support the change or routine activities and that all reports and protocols are reviewed and approved as appropriate.\nAccountable for planning, tracking and reporting for assigned validation projects or activities.\nOwn investigations in the event of failures or adverse trends; identify root cause, determine and complete corrective/preventative actions. Expected to seek subject matter experts (SME) and bring validation expertise, strong analytical and systematic problem-solving skills.\nSupervise and mentor validation technician(s) and supervise validation consultant(s) to provide project and technical direction, as needed.\nWork with supervision as needed and as provided by Sr. Validation Engineer or Manager\nAct as Change Control Owner for projects as required.\nAssess change controls; perform impact assessment based on knowledge of process and validation principles and policies.\nProvides technical training in validation to plant personnel \nWrite or assist with the writing of Standard Operating Procedures and Validation Master Plans\nReview and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications and policies\nInteract with Quality, Engineering, Manufacturing, Packaging, IT, and business area users as needed to understand processes, equipment functionality and use of automated control systems/computerized systems\nCommunicate and manage timelines for validation projects to project manager or site management\nAdditional travel may be required for Facility Acceptance Testing (FAT) of new equipment or technical transfer of new processes.\nPerform other related duties as assigned or required.\nKnowledge, Skills & Qualifications:\nMust have basic knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines. Knowledge in one of the following disciplines is required: Validation\nManufacturing\nFacilities/Utilities\nLaboratory\nSolution processes\nTerminal sterilization\nAutomated controls systems/software\n\nMust have good organizational, presentation, meeting facilitation and technical writing skills. \nWorking knowledge of statistics is preferred. \nRequires a high level of resourcefulness, an ability to get things done by removing obstacles, perceiving, and resolving problems, making difficult decisions with less than complete information provided, and finding ways to accomplish goals through innovative planning. \nMust maintain a thorough working knowledge of the ICU Medical Specification Systems. A high level of attention to details and the ability to proofread and audit validation documents is required. \nMust be able to work weekends and holidays as required to meet deadlines. \nEducation and Experience:\nBachelor’s Degree required: Engineering or Science (Engineering Preferred)\nCandidates with other technical bachelor’s degrees will be considered if they have two (2) or more years of direct validation experience. \nA minimum of two (2) years’ experience is required. Direct validation experience preferred. \nExperience interacting with regulatory and third-party representatives preferred. \nPrior supervisory experience is desirable but not required.\nMinimum Qualifications:\nMust be at least 18 years of age.\nTravel Requirements:\nTypically requires travel less than 5% of the time.\nPhysical Requirements and Work Environment:\nTime split between office and manufacturing environment. Some physical demands when working on the manufacturing floor executing validation runs.\nOccasional lifting. Must be able to lift up to 25 lbs unassisted.","description_format":"text","description_chars":5455,"description_truncated":false,"requirements":{"experience_years_min":2,"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":"2026-10-22T06:44:58Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.859,"p_room":1,"age_days":4,"expected_fill_days":23,"reasons":["conf:9","win:early"],"computed_at":"2026-10-26T05:57:25Z"},"pay":null,"html_url":"https://alion.io/job/otsukaicumed-validation-engineer-ii","json_url":"https://alion.io/job/otsukaicumed-validation-engineer-ii.json","meta":{"generated_at":"2026-10-26T18:03:01Z","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":24204,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":4423330},"rest":"https://alion.io/mcp/rest/get_company?id=4423330"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fotsukaicumed-validation-engineer-ii"},{"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%2Fotsukaicumed-validation-engineer-ii"},{"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%2Fotsukaicumed-validation-engineer-ii"},{"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/otsukaicumed-validation-engineer-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fotsukaicumed-validation-engineer-ii"}]}