{"id":1475091,"url":"https://alion.io/job/indivior-senior-engineer-validation","title":"Senior Engineer, Validation","company":{"id":1888114,"name":"Indivior","domain":"indivior.com","url":"https://alion.io/company/indivior","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"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":["Raleigh, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":88000,"max":105000,"currency":"USD","period":"year","gross":null,"usd_annual":105000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false}],"status":"live","first_seen_at":"2026-09-14T00:00:00Z","employer_posted_date":"2026-09-14","last_verified_at":"2026-10-24T17:27:11Z","board_verified":true,"closed_at":null,"days_open":41,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":41},"description":"TITLE:\nSenior Engineer, ValidationWHO WE ARE\nIndivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.\nPOSITION OVERVIEW\nWe are currently hiring an experienced Senior Validation Engineer to provide expertise, guidance, and maintenance of the Validation activities at the Raleigh, North Carolina site as well as alignment with Global procedures to ensure compliance with FDA and other related regulations. The Senior Validation Engineer must be the subject matter expert who leads the development, implementation and is the driver of continuous improvement for Indivior’s validation practices, policy, and procedures.\nHOW YOU’LL MAKE AN IMPACT\nThe Senior Validation Engineer will perform requalification and qualification of equipment and or processes within the facility. They will participate in FAT, SAT, engineering studies and commissioning activities. You will be a senior member of the validation team developing, reviewing, executing, and managing validation activities, and ensuring that the qualification/validation activities are consistent with user's/manufacturer's requirements and site quality standards.\nThe responsibilities of this job include, but are not limited to, the following:\nAuthor validation protocols (IQ/OQ/PQ) and final reports, write test scripts, user requirements and lead process validation activities for various manufacturing processes\n\nExecute requalification and validation protocols.\n\nOrganize and maintain validation documentation.\n\nTrack projects for timely delivery and consistency with regulatory requirements.\n\nUse of a Kaye Validator System or equivalent temperature mapping instruments.\n\nAbility to gown into aseptic areas.\n\nMaintain qualified equipment systems in compliance with policies, guidelines, and procedures.\n\nExecute and/or leads installation, commissioning activities of area specific process equipment, validation of SIP/CIP processes, qualification of environmental chambers and qualification of critical process utility systems.\n\nManage changes, deviations, investigations, and CAPAs via Veeva Vault.\n\nMaintain and manage positive working relationships while assisting in all stages of CAPA and change management and resolution.\n\nReview and participate in process validation, FMEA, and project remediation.\n\nAssess change controls, facility work orders and equipment risk assessments to ensure compliant/validated state of all GMP equipment and systems.\n\nInteract with FDA investigators regarding cleaning validation, equipment qualifications with respect to compliance issues and regulatory requirements.\n\nPerform deviation investigations and help to implement CAPA and re-validation as necessary.\n\nStreamline procedures for equipment and utility qualification and CSV using risk assessment and standardization.\n\nWell-versed in GMP/GXP procedures and validation requirements and experience at gathering technical information from vendors and user requirements.\n\nWorking knowledge of process automation and computer system validation concepts, GAMP methodologies, CFR Part 11 Electronic Records and Signatures requirements and latest industry expectations for data integrity.\n\nAbility to be impactful and influence people/areas in matters related to GxP compliance and regulatory adherence.\n\nA strong leader with respect to being a positive influence to support the growth of the organization as well as team members.\n\nAbility to work in a fast-moving dynamic organization with excellent change management skills.\n\nWHAT YOU’LL BRING\nBachelor’s degree in science or engineering field from an accredited university.\n\nA minimum of five (5) years of experience in production, engineering, environmental monitoring, quality control, mechanical or related fields are preferred. Ability to learn new processes and equipment independently is required. Must be proficient in Microsoft applications i.e. Word, Excel/formula builds.\n\nIn addition to the minimum qualifications, the employee will demonstrate:\nKnowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept.\n\nA plus to have experience in developing qualification protocols for laboratory instruments utilize for QC analytical and microbiological testing purposes.\n\nAbility to work in a team and cross-functionally when required.\n\nGood communication skills, written and oral.\n\nDeveloping influential skills in areas with no direct reporting authority.\n\nAbility to work independently to deliver outputs and through others as required.\n\nAttention to detail and great organization skills.\n\nAdept IT skills and ability to learn quickly.\n\nHOW WE INVEST IN OUR PEOPLE\nIndivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:\nPursuant to various state Fair Pay Acts, below is a summary of compensation elements for this role at the company. The following benefits are provided by Indivior, subject to eligibility requirements.\nStarting Salary: $88,000 - $105,000 USD\n*Note actual salary is based on qualifications and experience\nCompetitive PTO plus company closure from December 24th- January 1st\n\nEligible to participate in Indivior’s bonus program, based on company and individual performance\n\nComprehensive Medical, Dental, Vision, Life and Disability coverage\n\nHealth, Dependent Care and Limited Purpose Flex Spending and HSA options\n\nAdoption assistance\n\nTuition reimbursement\n\nConcierge/personal assistance services\n\nVoluntary benefits including Legal, Pet Insurance and Critical Illness coverage\n\nWellness programs as well as other discounts and perks\n\nOUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT\nIndivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behavior.\nEmployee Obligations:\nHave unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure\n\nRisk IQ: Know what policies apply to your role and function and adhere to them.\n\nSpeak Up: If you see something, say something.\n\nManager Obligations:\nHave unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure\n\nReinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.\n\nModel and reinforce a Speak Up culture on your team.\n\nEQUAL EMPLOYMENT OPPORTUNITY\nEOE/Minorities/Females/Vet/Disabled are encouraged to apply!\nThe duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.\nWant to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.","description_format":"text","description_chars":7538,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Wellness"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Addiction Treatment","Public Health & Prevention"],"lifecycle":[{"event":"open","at":"2026-09-29T18:36:15Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 2","filings_12m":2,"filings_prev_12m":3,"green_card_filings_12m":0,"median_offered_wage_usd":102500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":30,"band":"fade","label":"Fading","p_open":1,"p_active":0.657,"p_room":0.45,"age_days":41,"expected_fill_days":24,"reasons":["conf:12","win:tail"],"computed_at":"2026-10-25T05:49:26Z"},"pay":{"stated_usd_annual":105000,"is_top_pay":false},"html_url":"https://alion.io/job/indivior-senior-engineer-validation","json_url":"https://alion.io/job/indivior-senior-engineer-validation.json","meta":{"generated_at":"2026-10-25T16:27:28Z","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":23656,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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":1888114},"rest":"https://alion.io/mcp/rest/get_company?id=1888114"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Findivior-senior-engineer-validation"},{"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%2Findivior-senior-engineer-validation"},{"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%2Findivior-senior-engineer-validation"},{"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/indivior-senior-engineer-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Findivior-senior-engineer-validation"}]}