{"id":3299979,"url":"https://alion.io/job/replimune-laboratory-gxp-systems-specialist-ii","title":"Laboratory GxP Systems Specialist 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":"Biotech","role_family":"Biotech","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":["Abingdon, United Kingdom"],"countries":["GB"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":71000,"max_usd":170000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":136},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"21 CFR Part 11","optional":true},{"name":"Active Directory","optional":true},{"name":"JMP","optional":true},{"name":"LIMS","optional":true},{"name":"Windows","optional":true}],"status":"live","first_seen_at":"2026-10-26T19:48:51Z","employer_posted_date":"2026-10-26","last_verified_at":"2026-10-31T11:53:54Z","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 Laboratory GxP Systems Administrator is responsible for the administration, maintenance, compliance, and support of laboratory computerized systems used within a regulated GxP environment. The role serves as the primary liaison between laboratory users, Quality Assurance, IT, Validation, and system vendors to ensure laboratory systems remain secure, available, compliant, and maintained in a validated state.\nThis position is based in our Milton Park location and typically has a 5-day on-site expectation.\nKey responsibilities:\nLaboratory Computerized Systems Administration\nAdminister laboratory computerized systems, including user access management, system configuration, workflows, roles, permissions, reporting, and periodic access reviews.\n\nMaintain system inventories, asset records, software version information, backups, archives, and associated lifecycle documentation.\n\nCoordinate software installations, upgrades, patches, maintenance activities, and system monitoring, escalating issues and managing resolution with IT, vendors, and other stakeholders as required.\n\nSupport system reliability, cybersecurity, data integrity, disaster recovery, and troubleshooting of laboratory applications and instrument software.\n\nQuality and Compliance Activities\nAuthor, review, and support change controls, deviations, CAPAs, impact assessments, and other quality records associated with laboratory computerized systems.\n\nSupport validation inventories, compliance assessments, audit and inspection readiness activities, and serve as a subject matter expert during internal audits and regulatory inspections.\n\nVendor and Project Management\nCoordinate activities performed by software vendors, consultants, and external validation contractors, including review of vendor documentation, release notes, service reports, and software lifecycle records.\n\nParticipate in cross-functional projects involving laboratory systems and digital solutions, tracking deliverables, timelines, risks, and actions through implementation, testing, validation, and qualification activities, including FAT, SAT, commissioning, and qualification where applicable.\n\nTraining and Continuous Improvement\nDevelop and deliver user training, provide guidance on compliance and data integrity requirements, and support the development and revision of SOPs, work instructions, and lifecycle management procedures.\n\nDrive continuous improvement initiatives related to laboratory computerized systems, system administration practices, and computer system validation processes.\n\nOther Responsibilities\nEnsure all activities are performed in accordance with SOPs, cGMP requirements, GDocP requirements, quality standards, and safety procedures.\n\nMaintain personal training compliance and qualification requirements for assigned responsibilities.\n\nSupport laboratory and quality-related investigations involving computerized systems.\n\nParticipate in after-hours support activities when required for business continuity.\n\nEducational Requirements\nBachelor's degree in Life Sciences, Chemistry, Biotechnology, Engineering, Computer Science, Information Systems, or related discipline required.\n\nAdvanced degree or relevant professional certifications desirable.\n\nExperience and Skill Requirements\nMinimum 5-8 years of experience administering computerized systems in a regulated GxP environment.\n\n· Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+, Windows/Active Directory environments, laboratory systems, software lifecycle, periodic review, and supplier assessment.\nExperience with change control, deviations, CAPAs, and quality management systems.\n\n· Strong technical writing, communication, organization, stakeholder management, problem-solving, attention to detail, and ability to work independently and in cross-functional teams.\nPreferred Competencies\nExperience with viewLinc, Empower, SoftMax Pro GxP, PharmSpec, BlueMountain Regulatory Asset Manager, LIMS, QuantStudio Design and Analysis software, and / or JMP software.\n\nExperience with Computer System Validation (CSV) and Data Integrity principles.\n\nKnowledge of pharmaceutical, biotechnology, or cell and gene therapy laboratory operations.\n\nExperience supporting cloud-hosted and SaaS-based GxP applications.\n\nExperience assessing and implementing software updates and cybersecurity patches within a validated environment.\n\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":6185,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-26T23:21:38Z"}],"visa":[{"country":"GB","licensed_sponsor":true,"evidence":"Licensed UK visa sponsor (Skilled Worker, Senior or Specialist Worker)","filings_12m":null,"filings_prev_12m":null,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Skilled Worker; Global Business Mobility: Senior or Specialist Worker","cap_exempt":false,"checked_at":"2026-10-31T06:23:40+00:00","sources":["UK Home Office: register of licensed sponsors (workers)"],"filings_for_role_12m":0}],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":4,"expected_fill_days":51,"reasons":["conf:1","win:early"],"computed_at":"2026-10-31T05:58:55Z"},"pay":null,"html_url":"https://alion.io/job/replimune-laboratory-gxp-systems-specialist-ii","json_url":"https://alion.io/job/replimune-laboratory-gxp-systems-specialist-ii.json","meta":{"generated_at":"2026-10-31T13:31:28Z","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":20996,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-01T00:00:00Z"}},"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-laboratory-gxp-systems-specialist-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-laboratory-gxp-systems-specialist-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-laboratory-gxp-systems-specialist-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-laboratory-gxp-systems-specialist-ii\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Freplimune-laboratory-gxp-systems-specialist-ii"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3299979}},{"tool":"search_jobs","arguments":{"company":"replimune.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3299979},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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