{"id":2195073,"url":"https://alion.io/job/amgen-senior-engineer-system-owner-compliance","title":"Senior Engineer System Owner Compliance","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":79,"open_postings":451,"ghost_share":0.002,"stale_share":0.836,"repost_share":0.007,"time_to_fill_p50_days":27,"computed_at":"2026-10-21T05:46:15Z"}},"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":["Holly Springs, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":115494,"max":156257,"currency":"USD","period":"year","gross":null,"usd_annual":156257},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"Statistical Process Control","optional":true}],"status":"live","first_seen_at":"2026-10-09T19:05:54Z","employer_posted_date":"2026-10-09","last_verified_at":"2026-10-21T23:04:58Z","board_verified":true,"closed_at":null,"days_open":12,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":12},"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. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.\nSENIOR ENGINEER, SYSTEM OWNER COMPLIANCE\nWhat you will do\nLet’s do this. Let’s change the world. In this vital role you will partner across Facilities & Engineering, Manufacturing, Quality, Validation, Environmental Health & Safety, Supply Chain, Digital Technology & Innovation, and Capital Projects to ensure engineering activities support operational excellence while maintaining a constant state of inspection readiness.\nThe successful candidate will demonstrate strong engineering judgment, ownership, technical leadership, and a continuous improvement mindset while driving compliance, reliability, and exceptional customer service.\nProvide system ownership for Biopharmaceutical compliance programs. Identify, support, and/or lead implementation of engineering-based improvements or upgrades to the facility systems. This may include development of business case for improvement and identification of design requirements and then translation of requirements into process equipment/system design, specification and supporting the construction, startup, and validation of equipment.\nDevelop equipment maintenance programs, ensure the availability of spare parts, and coordinating maintenance execution as necessary to ensure systems are in proper working order.\nEnsure systems are installed and operating safety and comply with pertinent environmental health/safety practice, rules and regulations.\nEnsure necessary commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors as necessary.\nMonitor systems to identify performance risks and implement risk reduction strategies.\nProviding troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action.\nSupport new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.\nFacilities Quality & Compliance\nServe as the technical lead for Facilities Quality & Compliance programs supporting GMP manufacturing operations.\nEnsure facility systems, utilities, maintenance programs, engineering activities, and documentation remain compliant with cGMP regulations, Amgen standards, and engineering requirements.\nMaintain Facilities & Engineering in a continuous state of inspection readiness through proactive compliance monitoring and risk mitigation.\nPartner with Quality Assurance during internal audits, corporate audits, customer audits, and regulatory inspections.\nQuality Systems Ownership\nOwn facility-related Deviations from initiation through closure, including investigation leadership, root cause analysis, effectiveness verification, and timely implementation of corrective actions.\nLead structured investigations using risk-based methodologies including 5-Why, Fishbone, Kepner-Tregoe, and Human Performance principles.\nOwn engineering Change Controls, ensuring appropriate impact assessments, stakeholder alignment, and compliant implementation.\nOwn & Manage Deviations from initiation through timely closure, ensuring sustainable corrective and preventive actions.\nManage CAPAs from initiation through effectiveness verification, ensuring sustainable corrective and preventive actions.\nMonitor quality metrics, identify emerging compliance trends, and proactively mitigate risks.\nEngineering & Maintenance Excellence\nSupport commissioning, qualification, startup, and lifecycle management of facility systems and utilities.\nDevelop and approve engineering procedures, maintenance strategies, technical reports, and risk assessments, as needed.\nEnsure engineering documentation complies with Good Documentation Practices (GDP).\nContinuous Improvement\nChampion a continuous improvement mindset by simplifying processes, reducing compliance risk, improving equipment reliability, and enhancing operational performance.\nLead improvement initiatives utilizing Lean, Six Sigma, Operational Excellence, and data-driven decision making.\nBusiness Partnership\nBuild trusted partnerships across Manufacturing, Quality, Validation, EHS, Supply Chain, and Engineering.\nDemonstrate a proactive, customer service mindset by delivering responsive engineering solutions while balancing compliance, reliability, and business needs.\nInfluence cross-functional teams without direct authority while fostering ownership, accountability, and collaboration.\nWhat we expect of you\nWe are all different, yet we all use our unique contributions to serve patients. The Professional we seek is a person with these qualifications.\nBasic Qualifications:\nHigh school diploma / GED and 10 years Engineering experience OR\nAssociate’s degree and 8 years of Engineering experience OR\nBachelor’s degree and 4 years of Engineering experience OR\nMaster’s degree and 2 years of Engineering experience OR\nDoctorate degree\nPreferred Qualifications:\nBachelor’s degree in Chemical or Mechanical Engineering\n6+ years' of relevant work experience with 5+ years' experience in Biopharmaceutical operations/manufacturing environment\nAbility to analyze problems, develop and propose engineering solutions in a scientific manner using data-driven techniques and analyses (e.g., Data Analytics, Root Cause Analysis (RCA), Statistical Process Control (SPC), Six Sigma, Predictive Maintenance, etc.)\nExperience working in a regulated environment (e.g. cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems/processes such as change control, non-conformances, corrective and preventative actions, and qualifications/validation\nExperience applying engineering principles to the design and implementation of system modifications, introduction of new processes, and execution of capital projects\nUnderstanding of the execution process of capital projects in a GMP Biopharmaceutical Production facility including procurement, construction, startup, and validation\nUnderstanding of safety requirements working in a GMP Biopharmaceutical Production facility.\nIndependent, ambitious, organized, able to multi-task in project environments, and skilled in communication, facilitation, and teamwork\nGreat teammate prepared to work in and embrace a team based culture that relies on collaboration for effective decision-making\nStrong leadership, technical writing, and communication/presentation skills\nWork schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage\nAbility for domestic/international travel\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.\nThe expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.\nIn addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:\nA comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts\nA discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan\nStock-based long-term incentives\nAward-winning time-off plans\nFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.\nApply now and make a lasting impact with the Amgen team.\ncareers.amgen.com\nIn any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.\nApplication deadline\nAmgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.\nSponsorship\nSponsorship for this role is not guaranteed.\nAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, 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 and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.\nWe will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.\n.Salary Range\n115,494.60USD -156,257.40 USD","description_format":"text","description_chars":10540,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":["Flexible schedule","Retirement plans"],"hiring_locations":[],"hiring_excludes":[{"name":"Puerto Rico","iso":"PR"}],"relocation_offered":false,"industries":["Biotechnology","Health Care","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-09T19:05:54Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 372 · green card filings: 113","filings_12m":372,"filings_prev_12m":465,"green_card_filings_12m":113,"median_offered_wage_usd":136675,"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":49,"band":"ok","label":"Likely open","p_open":0.9,"p_active":0.604,"p_room":0.9,"age_days":11,"expected_fill_days":27,"reasons":["conf:60","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-21T05:46:15Z"},"pay":{"stated_usd_annual":156257,"is_top_pay":true},"html_url":"https://alion.io/job/amgen-senior-engineer-system-owner-compliance","json_url":"https://alion.io/job/amgen-senior-engineer-system-owner-compliance.json","meta":{"generated_at":"2026-10-22T02:09:36Z","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":1579,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"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":4775},"rest":"https://alion.io/mcp/rest/get_company?id=4775"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Famgen-senior-engineer-system-owner-compliance"},{"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%2Famgen-senior-engineer-system-owner-compliance"},{"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%2Famgen-senior-engineer-system-owner-compliance"},{"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-system-owner-compliance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-senior-engineer-system-owner-compliance"}]}