{"id":1432137,"url":"https://alion.io/job/siegfried-manufacturing-engineer-ii-process-expert","title":"Manufacturing Engineer II (Process Expert)","company":{"id":1865765,"name":"Siegfried","domain":"siegfried.ch","url":"https://alion.io/company/siegfried","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":14,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-09-29T05:45:00Z"}},"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":["Irvine, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":105000,"max":120000,"currency":"USD","period":"year","gross":null,"usd_annual":120000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-27T00:00:00Z","employer_posted_date":"2026-08-27","last_verified_at":"2026-09-29T19:05:04Z","board_verified":true,"closed_at":null,"days_open":34,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":34},"description":"\"Expect to grow\", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions-offeringlong-term opportunities to grow and make an impact.\nYour Role:\nAre you a pharmaceutical manufacturing engineer who thrives on solving complex technical challenges, improving processes, and driving operational excellence in a GMP environment? Join our growing CDMO team and play a critical role in supporting the production of therapies that make a meaningful difference in patients' lives.As a Manufacturing Engineer II (Process Expert), you will serve as a key technical resource for production processes and manufacturing instrumentation, driving process optimization, equipment qualification, investigations, technology transfers, and continuous improvement initiatives across API, formulation, aseptic fill-finish, inspection, and packaging operations.\nYour Profile:\nWhat You'll Do\nProvide technical support for GMP pharmaceutical manufacturing operations.\nOwn and maintain critical manufacturing documentation, including SOPs, Master Batch Records, protocols, risk assessments, investigations, and technical reports.\nLead or support equipment qualification activities (IQ/OQ/PQ), process validations, and continuous improvement projects.\nServe as the technical owner for production instrumentation, including calibration, preventive maintenance, troubleshooting, requalification, and repair coordination.\nLead investigations, root cause analyses, and corrective actions related to manufacturing events.\nPartner cross-functionally with Manufacturing, Quality, Engineering, and other stakeholders to ensure efficient, compliant, and reliable operations.\nSupport process optimization, implementation of new technologies, and introduction of new products.\nMaintain inspection readiness and ensure compliance with GMP, FDA, safety, and environmental requirements.\nProvide technical guidance and training to manufacturing personnel.\nSupport manufacturing operations directly as business needs require.\nQualifications\nRequired\nBachelor's degree in Engineering, Biological Sciences, or a related technical discipline.\n3+ years of experience supporting pharmaceutical, biotechnology, biologics, cell and gene therapy, or CDMO manufacturing operations in a GMP-regulated environment.\nExperience qualifying equipment and manufacturing processes in a regulated manufacturing environment.\nStrong technical writing, data analysis, troubleshooting, and problem-solving skills.\nWorking knowledge of GMP regulations, quality systems, and data integrity requirements.\nDemonstrated ability to manage multiple priorities in a fast-paced manufacturing environment.\nStrong communication and collaboration skills with the ability to influence and work effectively across cross-functional teams.\nPreferred\nExperience with aseptic processing and fill-finish operations, including equipment preparation, formulation, sterile filtration, and filling.\nExperience supporting API manufacturing, sterile manufacturing, or commercial pharmaceutical production.\nPrior aseptic fill-finish experience is preferred and will provide a strong foundation for success in this role due to the cross-functional support provided across sterile manufacturing operations.\nWork Environment\nUp to 50% of time spent supporting manufacturing operations on the production floor.\nAbility to safely lift, push, or pull materials and equipment up to 50 pounds, with or without reasonable accommodation.\nAbility to work in GMP manufacturing environments, including ISO 5 through ISO 8 classified cleanrooms, while wearing required gowning and PPE, including safety glasses, masks, gloves, hair coverings, scrubs, lab coats, and Tyvek suits.\nThis position supports a 24-hour pharmaceutical manufacturing operation and requires close partnership with production teams across manufacturing schedules.\nWhy Join Us?\nThis is an opportunity to broaden your expertise across the pharmaceutical manufacturing lifecycle while taking ownership of critical processes, equipment, and improvement initiatives in a growing CDMO environment. You'll gain exposure to API production, aseptic fill-finish manufacturing, process validation, continuous improvement, and cross-functional project leadership, all while contributing to the delivery of therapies that improve patients' lives.\nCompensation\nTarget Salary Range: $105,000 - $120,000\nIndividual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.\nYour Benefits:\nMedical, Dental, Vision\n\nFlexible Spending & HSA Options\n\nLife Insurance, Short & Long Term Disability\n\nPet Insurance\n\nGenerous PTO, Sick & Holiday Time Off\n\n401K\n\nFounded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.","description_format":"text","description_chars":5797,"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":["401k plan","Life insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-09-29T01:42:45Z"}],"liveness":{"score":26,"band":"fade","label":"Fading","p_open":1,"p_active":0.48,"p_room":0.55,"age_days":33,"expected_fill_days":31,"reasons":["conf:4","stale_co","win:tail"],"computed_at":"2026-09-29T05:45:00Z"},"pay":{"stated_usd_annual":120000,"is_top_pay":false},"html_url":"https://alion.io/job/siegfried-manufacturing-engineer-ii-process-expert","json_url":"https://alion.io/job/siegfried-manufacturing-engineer-ii-process-expert.json","meta":{"generated_at":"2026-09-30T01:32:42Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":1143,"day_limit":5000,"remaining_today":3857,"minute_limit":60,"resets_at":"2026-10-01T00:00:00Z"}}}