{"id":3021893,"url":"https://alion.io/job/amgen-engineer-process-development-commissioning-qualification-and-validation","title":"Engineer - Process Development (Commissioning, Qualification, and Validation)","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":"A","score":86,"open_postings":353,"ghost_share":0,"stale_share":0.578,"repost_share":0.003,"time_to_fill_p50_days":42,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["New Albany, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":88281,"max":119439,"currency":"USD","period":"year","gross":null,"usd_annual":119439},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-19T00:00:00Z","employer_posted_date":"2026-10-28","last_verified_at":"2026-10-29T01:28:23Z","board_verified":true,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":1,"flags":[],"days_open":10},"description":"Career Category\nProcess DevelopmentJob 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. 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.\nEngineer - Process Development (Commissioning, Qualification, and Validation)\nWhat you will do\nLet’s do this. Let’s change the world. In this role, you will support the commissioning, qualification, and validation (CQV) of GMP equipment and processes that enable Final Drug Product (FDP) operations at the Amgen Ohio (AOH) site. You will apply strong engineering and scientific principles to ensure new and existing systems meet Amgen and regulatory requirements throughout the validation lifecycle.\nAs a key contributor to AOH’s growth, you will play an essential role in technical transfer, equipment startup, process validation, and continuous improvement across automated device assembly, packaging, and FDP manufacturing operations. Your work will help ensure reliable, compliant, and efficient production systems that support Amgen’s mission of serving patients.\nKey responsibilities of this role include:\nCommissioning, Qualification & Validation (CQV)\nComplete commissioning activities and author/implement IQ/OQ/PQ protocols, validation plans, and lifecycle documentation.\nMaintain validated state of equipment and processes through periodic review and documentation updates.\nParticipate in equipment and system design review, supporting requirements definition and CQV strategy alignment.\nSupport and participate in FAT/SAT, equipment installation, and startup readiness.\nCollect and analyze process and equipment data to support validation, characterization, and sustained performance.\nTechnical Transfer & Process Support\nSupport technical transfer of FDP and combination product processes into AOH, ensuring CQV deliverables are met.\nPerform data collection and process characterization to support new equipment and process introductions.\nTrouble shoot device assembly and packaging equipment through engineering fundamentals and multi-functional support.\nProvide technical feedback into change control, deviations, CAPA, and risk assessments (as applicable to validation activities).\nProject Management & Multi-Functional Collaboration\nSupport CQV project planning, schedule alignment, and execution for new or modified equipment and systems.\nPartner with Manufacturing, Process Development, Engineering, and Quality to ensure project deliverables are met on time.\nMaintain effective communication with AOH site teams and the broader Amgen network to ensure alignment on technical deliverables.\nSupport documentation reviews, supplier interactions, and internal readiness for inspections or audits.\nTechnical Expertise & Equipment Support\nServe as a technical resource for automated and semi-automated device assembly and packaging equipment.\nSupport trouble shooting and lead investigations for technical issues impacting equipment performance or reliability.\nReview vendor documentation, test protocols, and engineering drawings to ensure compliance with CQV requirements.\nEvaluate equipment and process performance trends to identify improvement opportunities.\nOperational Excellence & Continuous Improvement\nIdentify and support improvements in throughput, reliability, and process capability across packaging and assembly operations.\nParticipate in Lean, Six Sigma, and Operational Excellence initiatives to strengthen equipment performance and CQV processes.\nSupport data-driven decision-making through process monitoring, trend analysis, and equipment performance assessments.\nRecommend enhancements to CQV procedures, templates, and standard methodologies to increase efficiency and compliance.\nPartner Relationships & Collaboration Network\nBuild collaborative relationships with key site and network groups, including:\nSite Process Development\nManufacturing & Quality Assurance\nEngineering & Maintenance\nGlobal Technical & Validation Networks\nExternal Equipment Suppliers\nLeverage this network to support equipment qualification, technical trouble shooting, validation standardization, and performance trending.\nTravel: Approximately 20%\nWhat we expect of you\nWe are all different, yet we all use our unique contributions to serve patients. The Process Development professional we seek is a leader with these qualifications.\nBasic Qualifications:\nMaster’s degree\nOr\nBachelor’s degree and 2 years in a GMP-regulated environment\nOr\nAssociate’s degree and 6 years in a GMP-regulated environment\nOr\nHigh school diploma / GED and 8 years in a GMP-regulated environment\nPreferred Qualifications:\nUnderstanding of combination product assembly technologies, automated and semi-automated equipment, and packaging operations.\nExperience supporting CQV activities, including protocol writing, execution, and data analysis.\nExcellent written and verbal communication skills together with demonstrated ability to work in a team environment.\nDemonstrated ability to contribute to cross-functional technical projects.\nExperience working with manufacturing equipment suppliers\nAbility to learn rapidly in a complex, fast-moving GMP environment.\nOperational Excellence mindset-Lean/Six Sigma exposure preferred.\nA passion to deliver an excellent work product and develop others with an infective positive attitude.\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.\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\n88,281.00USD -119,439.00 USD","description_format":"text","description_chars":8748,"description_truncated":false,"requirements":{"experience_years_min":null,"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":["Prescription Drugs","Biologics & Biosimilars","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-21T17:59:52Z"},{"event":"close","at":"2026-10-27T08:24:27Z"},{"event":"reopen","at":"2026-10-28T15:30:05Z"}],"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":84,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.842,"p_room":1,"age_days":10,"expected_fill_days":42,"reasons":["conf:2","win:early","comp:brand"],"computed_at":"2026-10-29T03:46:02Z"},"pay":{"stated_usd_annual":119439,"is_top_pay":false},"html_url":"https://alion.io/job/amgen-engineer-process-development-commissioning-qualification-and-validation","json_url":"https://alion.io/job/amgen-engineer-process-development-commissioning-qualification-and-validation.json","meta":{"generated_at":"2026-10-29T03:46:02Z","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":5800,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"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-engineer-process-development-commissioning-qualification-and-validation"},{"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-engineer-process-development-commissioning-qualification-and-validation"},{"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-engineer-process-development-commissioning-qualification-and-validation"},{"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-engineer-process-development-commissioning-qualification-and-validation\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Famgen-engineer-process-development-commissioning-qualification-and-validation"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3021893}},{"tool":"search_jobs","arguments":{"company":"amgen.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3021893},"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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