{"id":3561699,"url":"https://alion.io/job/lumen-process-engineer-ii-gmp-equipment-lifecycle","title":"Process Engineer II - GMP Equipment Lifecycle","company":{"id":11237,"name":"Lumen","domain":"lumen.bio","url":"https://alion.io/company/lumen","size_band":"11-50","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Seattle, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":80000,"max":110000,"currency":"USD","period":"year","gross":null,"usd_annual":110000},"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},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-08-27T17:43:52Z","employer_posted_date":"2026-08-27","last_verified_at":"2026-11-04T04:31:42Z","board_verified":true,"closed_at":null,"days_open":68,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":68},"description":"Process Engineer II - GMP Equipment Lifecycle\nLumen Bioscience is seeking a qualified Process Engineer who will be responsible for supporting Lumen's spirulina-based biomanufacturing platform through the lifecycle management of GMP manufacturing equipment.\nRole Description:\nGMP Equipment Lifecycle: Owning the onboarding, commissioning, qualification and validation of new GMP process equipment.\nPreventative maintenance management: Development and improvement of work instructions. Establishing cleaning and sanitization procedures.\nManufacturing Process: Partner closely with Engineering and Process Development teams to characterize and optimize manufacturing processes as it is executed on production-scale drug substance and drug product equipment.\nTeam Collaboration: Work closely with manufacturing operations, Quality, and supporting teams to implement procedures, programs, and training to enhance operational efficiency and compliance.\nEssential Duties and Responsibilities:\nServe as the technical owner for manufacturing equipment through its lifecycle: coordinating pre-purchase requirements, safety assessments, training, startup change control, periodic review and eventual decommissioning.\nTroubleshoot equipment and process failures and lead root cause investigations, corrective and preventative actions (CAPA), and reliability improvements to minimize downtime and improve contamination control.\nDesign, execute and analyze equipment and process-focused experiments - including optimization, scale-up and scale-down studies - to improve yield, throughput, robustness and product quality.\nAuthor, revise and continuously improve equipment operating procedures, work instructions, cleaning, set-up and changeover instructions, technical documentation including engineering studies and impact assessments, associated risk assessments and batch records steps to ensure safe, reproducible, compliant processes.\nSupport deviations, change controls, internal and external audits and regulatory inspections as the equipment subject matter expert.\nQualifications & Requirements:\n Educational Background: Bachelor’s degree in an engineering discipline (e.g. Mechanical, Chemical, Biomedical, Industrial) required.\nProfessional Experience: 5+years of relevant process or equipment engineering experience, preferably in a cGMP pharmaceutical, biotechnology, or medical device manufacturing environment.\n Technical Knowledge: Strong mechanical aptitude and hands-on equipment troubleshooting experience. Experience supporting equipment qualification and validation (IQ / OQ / PQ) and/or developing preventative maintenance programs.\n Technical Skills: Basic knowledge of food, dietary supplement, biotechnology and biomanufacturing processes per cGMP (21 CFR Part 111 / 117 / 210 / 211). Proficient in Microsoft Office Suite.\nPersonal Attributes: Detail-oriented, highly organized, proactive, with the ability to manage multiple tasks simultaneously in a fast-paced environment. Strong interpersonal skills and commitment to quality and ethical standards.\nPhysical Requirements:\nAbility to sit, stand and walk for extended periods (2+ hours) in a manufacturing or production environment.\nOccasionally lift or carry items up to 20 kg.\nAbility to gown and work in controlled and classified (cleanroom) environments and around production equipment.\nSalary & Benefits at Lumen Bioscience:\n$80,000 to $110,000 salary range, depending on experience.\nHealth, Dental, and Vision premiums fully covered by Lumen.\n401k match up to 4%.\nIndustry-leading PTO policy, paid refresh days, and paid year-end holiday office closure.\nMonthly wellness program to support your health and well-being.\nFree onsite parking or public transportation subsidies.\nComprehensive parental leave policies.\nLife insurance, short & long-term disability, and access to employee assistance programs.\nAt Lumen Bioscience, we foster a workplace that encourages innovation, collaboration, and professional growth. This role offers an opportunity to enhance your compliance expertise while contributing significantly to advancements in biotechnology and global health solutions.\nJoin us and play a crucial role in ensuring manufacturing compliance and quality excellence.\nCompensation Range\n$80,000—$110,000 USD","description_format":"text","description_chars":4277,"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":["401k plan","Life insurance","Parental leave"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Industrial Biotechnology"],"lifecycle":[{"event":"open","at":"2026-10-31T04:31:43Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 1","filings_12m":1,"filings_prev_12m":0,"green_card_filings_12m":0,"median_offered_wage_usd":57500,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":10,"band":"cold","label":"Long shot","p_open":1,"p_active":0.373,"p_room":0.28,"age_days":68,"expected_fill_days":29,"reasons":["conf:2","win:tail","crowd:"],"computed_at":"2026-11-04T06:34:25Z"},"pay":{"stated_usd_annual":110000,"is_top_pay":true},"html_url":"https://alion.io/job/lumen-process-engineer-ii-gmp-equipment-lifecycle","json_url":"https://alion.io/job/lumen-process-engineer-ii-gmp-equipment-lifecycle.json","meta":{"generated_at":"2026-11-04T07:37:06Z","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":11870,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-05T00:00:00Z"}},"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":11237},"rest":"https://alion.io/mcp/rest/get_company?id=11237"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flumen-process-engineer-ii-gmp-equipment-lifecycle"},{"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%2Flumen-process-engineer-ii-gmp-equipment-lifecycle"},{"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%2Flumen-process-engineer-ii-gmp-equipment-lifecycle"},{"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/lumen-process-engineer-ii-gmp-equipment-lifecycle\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flumen-process-engineer-ii-gmp-equipment-lifecycle"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3561699}},{"tool":"search_jobs","arguments":{"company":"lumen.bio","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3561699},"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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