{"id":1471062,"url":"https://alion.io/job/west-pharmaceutical-services-inc-quality-project-manager-sterilization","title":"Quality Project Manager - Sterilization","company":{"id":1923607,"name":"West Pharmaceutical Services","domain":"westpharma.com","url":"https://alion.io/company/westpharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Management","role_family":"Management","seniority":"middle","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Exton, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":64000,"max_usd":119000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":2117},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Mandiant capa","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-09-28T02:00:00Z","employer_posted_date":"2026-09-28","last_verified_at":"2026-10-27T04:09:17Z","board_verified":true,"closed_at":null,"days_open":29,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":29},"description":"This is a hybrid position requiring the team member to be onsite a minimum of 3 days per week. No relocation is provided for this opportunity.\nAt West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?\nThere’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.\nWe believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.\n Job Summary\nThe Quality Project Manager - Sterilization is responsible for leading and executing sterilization-related quality initiatives across manufacturing sites. This role combines strong sterilization technical expertise (EtO, steam, gamma) with structured project management capabilities to drive standardization, compliance, continuous improvement, and quality maturity. The position supports the development and implementation of standardized sterilization processes, validation programs, and QMS improvements while ensuring compliance with FDA, ISO 13485, and applicable regulatory standards. This role works cross-functionally with Engineering, Operations, Regulatory, R&D, and Quality teams to execute projects on time, within scope, and within budget.\nEssential Duties and Responsibilities\nSupport the development, harmonization, and deployment of standardized sterilization procedures and quality practices across multiple sites.\nCoordinate sterilization validation activities, including initial process validations, revalidations, and annual re-qualifications to maintain a validated state.\nAuthor, review, and approve sterilization protocols, validation reports, technical documentation, and related procedures in accordance with internal standards and regulatory requirements.\nEnsure compliance with FDA regulations (21 CFR 820), ISO 13485, applicable cGMP requirements, and other global regulatory standards.\nSupport environmental monitoring programs and implement risk-based validation and control strategies.\nMonitor, track, and trend sterilization process data to identify improvement opportunities, ensure process capability, and maintain compliance.\nParticipate in regulatory inspections and audits and provide front-room and back-room support for sterilization-related activities.\nLead cross-functional sterilization and quality improvement projects from initiation through closure, ensuring alignment with business objectives.\nDevelop project charters, timelines, resource plans, and budgets, and identify, assess, and mitigate project risks throughout the project lifecycle.\nManage project scope, schedule, and cost controls using structured project management methodologies.\nAssemble and coordinate cross-functional project teams, define clear deliverables, and ensure accountability.\nMeasure and report project performance using defined KPIs and quality metrics and communicate progress, risks, and outcomes to key stakeholders.\nSupport standardization and continuous improvement of quality systems and sterilization practices across sites.\nLead or contribute to CAPA, root cause analysis, FMEA, and broader risk management activities to address quality and compliance gaps.\nDevelop, analyze, and report quality performance metrics related to sterilization effectiveness and cost of quality.\nDrive Lean and Six Sigma initiatives to improve sterilization cycle efficiency, strengthen compliance robustness, and optimize cost performance.\nCoordinate corrective and preventive actions resulting from customer complaints, audit findings, or operational nonconformances.\nCollaborate closely with Engineering, R&D, Operations, and Regulatory teams to support product and process transfers, validations, and continuous improvements.\nSupport evaluation and implementation of new sterilization technologies, industry best practices, and process enhancements.\nEnsure proper change control processes are followed, including completion of risk assessments, impact analyses, and FMEA documentation.\nAdditional Responsibilities\nWorks independently with minimal guidance.\nDevelops technical knowledge, requires working knowledge and experience in project management.\nManages single workstreams locally/globally and may work across multiple workstreams.\nMaintain clear communication paths with stakeholders.\nConforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.\nExhibits regular, reliable, punctual and predictable attendance.\nWhile performing the duties of this job, the employee is regularly required to, sit, stand, walk, talk, hear, see and use hands and fingers to operate office equipment (ie phones, computers, copies, etc.).\nThe employee occasionally works in clean room environments requiring special gowning and training to operate in these environments.\nThe noise level in the office work environment is usually quiet. The noise level in the manufacturing work environment is moderate to loud. Hearing protection is required as posted in the manufacturing work environment.\nJob requires mental skill or ability such as communication, decision making (sometimes quick), interpreting data, reading, or writing, organization, problem solving, understand direction, etc.\nEducation\nBachelor's Degree Science related field, Chemistry, Biology, engineering required\nWork Experience\nPreferred previous ETO, steam/gamma sterilization experience\n3+ years experience in a similar position within the manufacturing industry\nGood knowledge of LEAN and 6 sigma manufacturing principles\nVery good organizational and project management skills\nExcellent communication skills and ability to successfully collaborate with teams across different countries and organizational levels\nHighly analytical and structured way of working\nSelf-motivated, results- and solution-oriented personality\nPreferred Knowledge, Skills and Abilities\nGeneral knowledge of OSHA/EPA/safety regulations, manufacturing, and process automation\nMaintain an awareness of “state of the art” technology as it applies to our industry. Take part in educational programs pertinent to process projects\nWorking knowledge of business and shop floor systems to effectively manage operations; prefer SAP and MS Office applications\nExperience working with ISO13485, FDA and cGMP preferred \nUnderstanding and experience in use of Lean manufacturing principles preferred\nAbility to write routine reports, correspondence, and process documents\nExcellent organizational and communication skills.\nWorks independently with minimal guidance\nAble to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description\nAble to comply with the company’s safety policy at all times #LI-AP1 #LI-HYBRID\nLicense and Certifications\nManufacturingSix Sigma Green Belt Certification preferred\nTravel Requirements\n10%: Up to 26 business days per year\nPhysical Requirements\nSedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.\nWest embraces diversity and equality of opportunity. We foster an environment where all individuals are safe, treated fairly, valued and respected. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, disability status or other applicable legally protected characteristics. Where permitted by law, employment with West Pharmaceutical Services, Inc. or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of post-offer background screening.","description_format":"text","description_chars":8431,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":true,"industries":["Health Care","Manufacturing","Infusion & Drug Delivery Devices"],"lifecycle":[{"event":"open","at":"2026-09-29T16:12:30Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 16 · green card filings: 7","filings_12m":16,"filings_prev_12m":17,"green_card_filings_12m":7,"median_offered_wage_usd":104457,"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":42,"band":"fade","label":"Fading","p_open":1,"p_active":0.765,"p_room":0.55,"age_days":28,"expected_fill_days":25,"reasons":["conf:3","velocity","win:tail","comp:brand"],"computed_at":"2026-10-26T05:57:25Z"},"pay":null,"html_url":"https://alion.io/job/west-pharmaceutical-services-inc-quality-project-manager-sterilization","json_url":"https://alion.io/job/west-pharmaceutical-services-inc-quality-project-manager-sterilization.json","meta":{"generated_at":"2026-10-27T04:27:02Z","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":4014,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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":1923607},"rest":"https://alion.io/mcp/rest/get_company?id=1923607"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fwest-pharmaceutical-services-inc-quality-project-manager-sterilization"},{"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%2Fwest-pharmaceutical-services-inc-quality-project-manager-sterilization"},{"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%2Fwest-pharmaceutical-services-inc-quality-project-manager-sterilization"},{"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/west-pharmaceutical-services-inc-quality-project-manager-sterilization\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fwest-pharmaceutical-services-inc-quality-project-manager-sterilization"}]}