{"id":1979221,"url":"https://alion.io/job/replimune-validation-engineer-ii","title":"Validation Engineer II","company":{"id":2285234,"name":"Replimune","domain":"replimune.com","url":"https://alion.io/company/replimune","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Framingham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":137000,"max":177000,"currency":"USD","period":"year","gross":null,"usd_annual":177000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Ignite","optional":false},{"name":"PyTorch","optional":true}],"status":"live","first_seen_at":"2026-10-06T21:02:13Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-10-11T00:34:29Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Overview\nReplimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care becausepatient’s lives depend on it.\nAt Replimune, we live by our values:\nUnited: We Collaborate for a Common Goal.\nAudacious: We Are Bold.\nDedicated: We Give Our Full Commitment.\nCandid: We Are Honest With Each Other.\nPeople are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, a strong and evolving culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to impact on the lives of patients, caregivers and themselves.\nJoin us, as we reshape the future.\nSummary of job description:\nThe Validation Engineer II will work as part of a larger validation team to ensure the biotech facility equipment, utilities, instrumentation and computerized systems are qualified and maintained in a validated state in accordance with appropriate regulatory guidance. The individual will work with internal customers and external contractors to coordinate scheduling, execution, and review of qualification protocols / reports. The individual will manage CQV campaigns to support maintaining CQV through change control, assessments, performance monitoring and requalification assessments.\nThis position is based in our Framingham location and typically has a 5-day on-site expectation.\n\nKey responsibilities:\nConduct impact and risk assessments and support the development of user requirement specifications, as needed.\n\nAuthors qualification, validation, and revalidation protocols and reports for facility, equipment, and critical utilities.\n\nEnsure validation documentation complies with industry standards, approved procedures, and current regulatory requirements.\n\nIndependently execute validation activities with limited supervision while identifying, communicating, and escalating project risks and compliance concerns as appropriate.\n\nCoordinate scheduling, execution, and review of qualification and validation protocols and reports.\n\nCoordinate and oversee vendors and contractors performing qualification activities.\n\nCollaborate with Engineering, Manufacturing, Quality Assurance, and other functional areas to support validation and qualification activities.\n\nReview, revise, and complete documentation in accordance with cGMP and GDP.\n\nSupport change controls and deviations by performing impact assessments related to the validated status of utilities, equipment, instruments, and systems.\n\nAssist with trouble shooting equipment and system failures and support investigations, as required.\n\nResponsible for other duties and projects as assigned.\n\nOther responsibilities\nEnsure that all work is performed in accordance with Standard Operating Procedures (SOPs), Current Good Manufacturing Practices (cGMP), quality standards, and safety procedures.\n\nSupport equipment and process related non-conformance investigations and change control activities.\n\nAssist with internal and regulatory agency audits / inspections.\n\nEnsure training is kept in GMP compliant state.\n\nEducational requirements:\nBachelor’s degree in Scientific, Engineering or similar subject required, MSc preferred.\n\nExperience and skill requirement:\nA minimum of five years professional experience in validation, engineering, or operations.\n\nA minimum of three years relevant experience in a cGMP environment is preferred.\n\nExperience with GMP utilities and equipment is required.\n\nExcellent communication and interpersonal skills are required.\n\nAttention to detail, flexibility and technical writing skills are important for this position.\n\nGood knowledge cGMP & GDP requirements\n\nAbility to work independently or in a team environment as well as being self-motivated and showing initiative.\n\nSalary Range\nReplimune is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $137,000-$177,000. The exact base pay offered for this role will depend on various factors, including but not limited to the selected candidate’s unique set of qualifications, skills, and experience. Our current organizational needs also play a part in determining your final offer.\nAt Replimune, base pay is only one part of your total compensation package. The selected candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Replimune also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays including year-end shutdown.\nAbout Replimune\nReplimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.\nWe are an Equal Opportunity Employer.","description_format":"text","description_chars":5816,"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":["401k plan","Equity","Flexible time off","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-06T22:33:51Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"green card filings: 4","filings_12m":0,"filings_prev_12m":12,"green_card_filings_12m":4,"median_offered_wage_usd":122500,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+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":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":3,"expected_fill_days":42,"reasons":["conf:1","velocity","win:early"],"computed_at":"2026-10-10T05:45:15Z"},"pay":{"stated_usd_annual":177000,"is_top_pay":true},"html_url":"https://alion.io/job/replimune-validation-engineer-ii","json_url":"https://alion.io/job/replimune-validation-engineer-ii.json","meta":{"generated_at":"2026-10-11T02:53:37Z","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","counted_by":"address","units_charged":1,"used_today":229,"day_limit":5000,"remaining_today":4771,"minute_limit":60,"resets_at":"2026-10-12T00:00:00Z"}},"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":2285234},"rest":"https://alion.io/mcp/rest/get_company?id=2285234"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Freplimune-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%2Freplimune-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%2Freplimune-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/replimune-validation-engineer-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Freplimune-validation-engineer-ii"}]}