{"id":2977988,"url":"https://alion.io/job/otsukaicumed-senior-validation-engineer","title":"Senior Validation Engineer","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":"senior","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":89000,"max_usd":167000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":6333},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-20T18:54:59Z","employer_posted_date":"2026-10-20","last_verified_at":"2026-10-26T23:25:24Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"Position Summary\nCompletes advanced validation projects with peer input and guidance from engineering and validation management. A specialist on complex technical and business matters. Work is highly independent. May assume a team lead role for the work group. May also lead validation contract support and be responsible for tracking validation hours and budget.\nEssential Duties & Responsibilities\nAnalyzes, plans, organizes and completes projects of a very complex nature. Develops scope and provides creative solutions. Plans, organizes and conducts technical projects. Consolidates results of design elements of major projects for purpose of design review. Integrates subsystems and components in total systems design. Develops specifications from customer requirements.\nReceives general project direction. Responsible for project progress.\nPrepares, reviews, and executes computerized system validation protocols per local procedures and Food and Drug Administration (FDA) regulations.\nDecisions consistently affect multiple or critical projects in the business and may impact external relationships.\nServe as project coordinator or project manager for validation/qualification aspects of projects.\nDelivers communications tailored to the needs of the receiver (managers, peers, customers) with appropriate frequency to maximize its utility and promote cross-functional collaboration. Brings substantive conflicts and disagreements into the open and attempts to resolve them collaboratively; builds consensus\nManages training new/current employees with respect to documentation, use of equipment, laboratory techniques and department procedures. May routinely monitor or supervise the work of one or more employees. Provides input on performance evaluations to area manager.\nWork on special projects as they arise\nSupport inspection readiness, participate in regulatory agency inspections and provide audit support, as required.\nLead continuous improvement activities for the validation program and revise, create and approve validation documents and procedures\nDevelop technical assessments using engineering principals and standards to support leveraging existing validation studies for changes that do not represent a new worst case.\nKnowledge, Skills & Qualifications\nHas an advanced understanding of validation and regulatory requirements \nCan assess what work supports the validation strategy and make insightful recommendations regarding priorities\nExpert in equipment, utilities and facilities domains of validation. Familiar in other areas of domain expertise within the team.\nExperience using project management tools is a plus.\nEducation and Experience\nBachelor’s degree from an accredited college or university\n7+ years of validation, science/technical or engineering background required, pharmaceutical validation or engineering experience preferred.\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\nThis is largely a sedentary role. \nThis job operates in a professional office environment and routinely uses standard office equipment.\nWork may be performed in a clean room environment\nMust be able to occasionally move and lift objects of up to 25 lbs.","description_format":"text","description_chars":3293,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":[],"lifecycle":[{"event":"open","at":"2026-10-21T05:34:20Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":6,"expected_fill_days":28,"reasons":["conf:6","win:early"],"computed_at":"2026-10-27T05:46:45Z"},"pay":null,"html_url":"https://alion.io/job/otsukaicumed-senior-validation-engineer","json_url":"https://alion.io/job/otsukaicumed-senior-validation-engineer.json","meta":{"generated_at":"2026-10-27T08:36:26Z","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":9465,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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-senior-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%2Fotsukaicumed-senior-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%2Fotsukaicumed-senior-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/otsukaicumed-senior-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fotsukaicumed-senior-validation-engineer"}]}