{"id":4346240,"url":"https://alion.io/job/amgen-senior-engineer-validation-utilities","title":"Senior Engineer, Validation - Utilities","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":80,"open_postings":336,"ghost_share":0,"stale_share":0.789,"repost_share":0.018,"time_to_fill_p50_days":42,"computed_at":"2026-11-15T07:52:55Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Dublin, Ireland"],"countries":["IE"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":74291,"max":100512,"currency":"EUR","period":"year","gross":null,"usd_annual":110853},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-11-13T00:00:00Z","employer_posted_date":"2026-11-13","last_verified_at":"2026-11-15T21:57:36Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Career Category\nEngineeringJob Description\nJoin Amgen’s Mission of Serving Patients\nAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.\nSince 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.\nOur award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.\nJob Spec: Senior Engineer, Validation - Utilities\nThe Senior Engineer, Validation - Utilities will provide technical validation support for new, modified and existing utility systems at Amgen Dun Laoghaire. The role will support the full validation lifecycle from project design and qualification through handover, change management and validation maintenance, ensuring activities are completed safely, in accordance with schedule and in compliance with GMP, regulatory and site quality requirements.\nThe successful candidate will work closely with Engineering System Owners, Quality, Operations, Maintenance, Automation, Project Management and external delivery partners. The role will provide validation governance for assigned utilities, including inspection readiness, validation change assessments, development of user requirements and quality risk assessments, and definition of appropriate risk-based qualification approaches.\nWhat you will do:\nKey Responsibilities:\nProvide technical validation support for assigned utility systems across the full lifecycle from initial design through commissioning, qualification, handover and validation maintenance.\nAct as the Validation lead for assigned utility systems and projects, working in partnership with the Engineering System Owner and relevant cross-functional stakeholders.\nLead or approve validation impact assessments for changes to utility systems,\nDetermine the validation deliverables and level of qualification required based on system classification, intended use, change complexity and risk.\nLead the development, review and approval of User Requirement Specifications (URS) and Quality Risk Assessments for Equipment and Automated Systems (QRAES).\nDevelop and approve risk-based commissioning and qualification approaches, including use of prior knowledge, vendor documentation, equivalency or family strategies, bracketing, worst-case selection and leveraged testing where justified.\nDevelop, review or approve C&Q plans, validation plans, test strategies, FAT, SAT, installation verification, functional testing, qualification summary reports and other qualification activities, as applicable.\nEnsure qualification requirements and acceptance criteria are clear, traceable and aligned with approved requirements and identified critical aspects.\nProvide technical oversight during qualification execution, including readiness reviews, field / walkdown support, assessment of exceptions or test failures and confirmation of appropriate corrective actions.\nEnsure validation commitments within change controls are clear, proportionate, appropriately sequenced and supported by suitable closure evidence, to ensure utility systems remain in a validated state.\nSupport the handover of utility systems to operational ownership, ensuring validation prerequisites, qualification records and lifecycle requirements are complete and appropriately controlled.\nMaintain assigned validation records in a state of inspection readiness and support internal audits, regulatory inspections, regulatory filings and responses to questions.\nProvide validation support for deviations, discrepancies, CAPAs and investigations that may affect utility systems or the qualified state.\nIdentify validation compliance or lifecycle gaps and lead or support practical remediation actions with Engineering System Owners and Quality.\nUpdate and maintain validation procedures, guidance and standard work in accordance with site and corporate requirements.\nSupport continuous improvement of the validation lifecycle process using lessons learned, metrics, recurring issues and current industry practice.\nProvide technical guidance and coaching to engineers, contractors and project teams on risk-based validation and documentation expectations.\nPlan and coordinate validation activities, priorities, dependencies and deliverables across multiple projects and operational needs.\nTake ownership for quality and compliance in assigned activities and escalate significant risks to the qualified state in a timely manner.\nUtilities Scope:\nThe role may support clean and plant utilities supplying clean utilities and their associated distribution systems, controls, instrumentation and interfaces. Utility systems may include purified water, water for injection, clean steam, process gases (compressed air, nitrogen), and their automation interfaces.\nWhat we expect of you:\nEducation / Experience:\nMaster’s degree in Engineering, Science or a related technical discipline with at least 3 years of relevant Validation, Commissioning and Qualification, Engineering or Quality experience; or a Bachelor’s degree with at least 5 years of relevant experience.\nDemonstrated experience working in a cGMP pharmaceutical or biotechnology manufacturing environment.\nExperience in the qualification and lifecycle management of GMP utility systems, preferably within sterile drug product, biologics or a comparable regulated manufacturing environment.\nStrong understanding of risk-based commissioning and qualification and the application of validation lifecycle principles.\nDemonstrated experience developing or reviewing URS, QRAES, validation impact assessments, qualification strategies, protocols, reports and traceability documentation.\nExperience assessing system changes and interfaces involving automation, instrumentation, calibration, maintenance, sampling or monitoring.\nExperience supporting regulatory inspections, internal audits or inspection-readiness activities is preferred.\nStrong technical judgment and problem-solving capability, with the ability to make clear and defensible recommendations in complex situations.\nAbility to manage multiple priorities, work independently and influence cross-functional stakeholders without direct authority.\nExcellent written and verbal communication skills and the ability to provide technical direction to engineers, contractors and project teams.\nKnowledge of applicable safety, GMP, data integrity and environmental regulatory requirements.\nRole clarification: This is a senior individual contributor position. This role provides Validation ownership of the qualification strategy, validation impact assessment and evidence supporting the qualified state.\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\nAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.\nAmgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.\nWe provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.\n.Salary Range\n74,291.70 EUR - 100,512.30 EUR","description_format":"text","description_chars":8477,"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":[{"name":"Ireland","iso":"IE","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-15T21:57:36Z"}],"visa":[{"country":"IE","licensed_sponsor":true,"adverts_offering_sponsorship_24m":0,"sanctioned_now":false,"evidence":"Irish employment permits in 12 months: 5","filings_12m":5,"filings_prev_12m":7,"green_card_filings_12m":null,"median_offered_wage_usd":null,"route":"Employment permits","cap_exempt":false,"checked_at":"2026-11-15T09:21:55+00:00","sources":["Department of Enterprise, Trade and Employment: employment permits issued to companies"],"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":2,"expected_fill_days":42,"reasons":["conf:1","win:early","comp:brand"],"computed_at":"2026-11-15T23:19:20Z"},"pay":{"stated_usd_annual":110853,"is_top_pay":false},"html_url":"https://alion.io/job/amgen-senior-engineer-validation-utilities","json_url":"https://alion.io/job/amgen-senior-engineer-validation-utilities.json","meta":{"generated_at":"2026-11-15T23:19:20Z","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":20013,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-16T00:00:00Z"}},"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-senior-engineer-validation-utilities"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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-senior-engineer-validation-utilities"},{"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-senior-engineer-validation-utilities"},{"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-senior-engineer-validation-utilities\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-senior-engineer-validation-utilities"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4346240}},{"tool":"search_jobs","arguments":{"company":"amgen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4346240},"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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