{"id":174572,"url":"https://alion.io/job/amgen-plm-software-quality-validation-engineer","title":"PLM Software Quality & Validation Engineer","company":{"id":4775,"name":"Amgen","domain":"amgen.com","url":"https://alion.io/company/amgen","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":334,"ghost_share":0,"stale_share":0.668,"repost_share":0.015,"time_to_fill_p50_days":43,"computed_at":"2026-11-09T06:03:00Z"}},"role":"QA","role_family":"QA","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":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":13500,"max_usd":34000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":35},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Agile","optional":false},{"name":"CI/CD","optional":false},{"name":"GMP","optional":false},{"name":"21 CFR Part 11","optional":true}],"status":"live","first_seen_at":"2025-09-30T00:00:00Z","employer_posted_date":"2025-07-03","last_verified_at":"2026-11-09T10:49:07Z","board_verified":true,"closed_at":null,"days_open":405,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":405},"description":"Career Category\nQualityJob Description\nLet’s do this. Let’s change the world. In this vital role you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and align with Amgen’s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and alignment to required standards so that the engineering teams can build and deploy products that are compliant.\nRoles & Responsibilities:\nThe ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta.\n\nDevelop and maintain comprehensive test plans for 3DExperience platform modules and application\n\nInvolve actively in release planning and estimate test efforts\n\nTest in an Agile development environment, analyze and communicate test results to team and manager\n\nDevelop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports.\n\nEnsure validation strategies meet regulatory requirements and company standards.\n\nStay updated on relevant changes to Amgen’s SOPs and ensure validation practices are aligned with evolving standards.\n\nAssist with UAT, test data preparation and developing work instructions.\n\nContribute to test automation scripting, framework maintenance, and CI/CD integration.\n\nImplement automated test suites across various modules in 3DEXPERIENCE.\n\nAnalyze test automation results, identify failures or inconsistencies, and assist in root cause analysis.\n\nCollaborate with multi-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines.\n\nWork closely with manager on implementing automation strategies, document all bugs in a tracking tool, and always follow best QA practices\n\nEnsure timely and effective completion of all validation activities in line with project objectives and schedules.\n\nEnsure proper documentation of validation activities, including deviations, change control, and non-conformance management.\n\nFind opportunities for process improvements in validation activities.\n\nKnow the latest on new technologies, validation trends, and industry standard processes to improve validation efficiencies.\n\nCollaborate and communicate effectively with the product teams and Dassault to pursue issue resolution.\n\nBasic Qualifications:\nMaster's degree / Bachelor's degree and 5 to 9 years of experience in Software Quality and GMP Validation\n\nPreferred Qualifications:\nFunctional Skills:\nMust-Have Skills:\nExperience in Quality Assurance (QA) testing with experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions.\n\nExperience in validation in a GMP-regulated environment (pharmaceutical, biotech, medical devices, etc.).\n\nOverall experience in developing, executing and analyzing QA & Test Automation\n\nProficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation.\n\nExperience with computer system validation and software validation.\n\nStrong problem-solving and analytical skills.\n\nGood-to-Have Skills:\nUnderstanding of 3DExperience platform architecture, modules, and integration points is highly desirable\n\nExperience with automated and computer-controlled systems validation (21 CFR Part 11)\n\nSoft Skills:\nExcellent analytical and troubleshooting skills.\n\nStrong verbal and written communication skills\n\nAbility to work effectively with global, virtual teams\n\nHigh degree of initiative and self-motivation.\n\nAbility to manage multiple priorities successfully.\n\nTeam-oriented, with a focus on achieving team goals.\n\nAbility to learn quickly, be organized and detail oriented.\n\nStrong presentation and public speaking skills.\n\nWhat you can expect of us\nAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.\nIn addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.\nApply now and make a lasting impact with the Amgen team.\ncareers.amgen.com\n.","description_format":"text","description_chars":4443,"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":["Prescription Drugs","Biologics & Biosimilars","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-08-30T06:12:42Z"}],"visa":[],"liveness":{"score":5,"band":"cold","label":"Long shot","p_open":1,"p_active":0.162,"p_room":0.28,"age_days":405,"expected_fill_days":43,"reasons":["conf:0","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-09T06:03:00Z"},"pay":null,"html_url":"https://alion.io/job/amgen-plm-software-quality-validation-engineer","json_url":"https://alion.io/job/amgen-plm-software-quality-validation-engineer.json","meta":{"generated_at":"2026-11-09T14:12:56Z","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":19235,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-10T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":4775},"rest":"https://alion.io/mcp/rest/get_company?id=4775"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famgen-plm-software-quality-validation-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":2,"usd":0.2},"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%2Famgen-plm-software-quality-validation-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Famgen-plm-software-quality-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/amgen-plm-software-quality-validation-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-plm-software-quality-validation-engineer"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":174572}},{"tool":"search_jobs","arguments":{"company":"amgen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":174572},"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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