{"id":2043902,"url":"https://alion.io/job/grail-senior-process-engineer-compliance","title":"Senior Process Engineer - Compliance","company":{"id":3593,"name":"GRAIL","domain":"grail.com","url":"https://alion.io/company/grail","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Lever","truth_index":null},"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":["Durham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":80000,"max_usd":153000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":5037},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-07T18:04:54Z","employer_posted_date":"2026-10-07","last_verified_at":"2026-10-12T16:30:29Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"The Senior Process Engineer leads complex investigations, compliance related initiatives and supports document management processes. This role is primarily responsible for driving quality management system (QMS) activities across engineering, validation, clinical laboratory and operations, including change control management, SOP lifecycle oversight, nonconformance (NC) and CAPA metrics management, training compliance, and continuous process improvement. The Senior Process Engineer works across functions to design and implement process improvements, serve as a technical resource to peers and technicians, and ensure compliance with regulatory and quality requirements.\nIn addition, this role provides advanced technical expertise in high-complexity molecular diagnostic workflows supporting the Galleri® assay and collaborates cross-functionally to ensure operational excellence, regulatory readiness, and sustained compliance with applicable regulatory and accreditation requirements.\nThis position works full time onsite in Durham, NC.\nResponsibilities:\nLead and own quality management system (QMS) activities, including change controls, document control, SOP revisions, deviations/nonconformances (NCs), and corrective and preventive actions (CAPAs).\n\nDevelop and maintain work instructions, guidelines, verifications, and standard operating procedures.\n\nIndependently investigate and resolve process deviations, applying root cause analysis and implementing effective corrective and preventive actions.\n\nSupport internal audits, external inspections, and regulatory assessments; prepare documentation, evidence packages, and responses to audit observations.\n\nPartner cross-functionally with Quality Assurance, Regulatory Affairs, Engineering Operations, Validation, and Clinical Operations leadership to implement and sustain compliant processes.\n\nIdentify process gaps, compliance risks, and operational inefficiencies; recommend and implement sustainable corrective actions and process improvements.\n\nMentor and train personnel on workflows, quality processes, and regulatory expectations.\n\nProvide technical guidance and support to engineers and technicians to promote process understanding and standardization.\n\nPrepare and present technical reports, proposals, and recommendations to management for process enhancements and cost savings.\n\nDevelop training compliance processes, including assignment, completion tracking, and on the job training assessments.\n\nThese job duties are a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.\n\nRequired Qualifications:\nBachelor’s degree in Engineering (Chemical, Mechanical, Industrial, or related field) with 5+ years of relevant experience, or Master’s degree with 3+ years of relevant experience, or PhD with 2+ years of relevant experience.\n\nDemonstrated level of knowledge regarding applicable regulatory standards commensurate with the position's complexity and scope, contributing to organizational regulatory compliance. Minimal applicable standards for this position include:\n\nGMP quality management systems (e.g. ISO 13485)\n\nClinical laboratory regulations (e.g. CAP, CLIA, NYSDOH, ISO 15189)\n\nOperations within the regulated medical device environment (e.g. IVDD, IVDR, FDA 21 CFR 800 series, FDA 21 CFR Part 11)\n\nExperience supporting audits, inspections, and regulatory readiness activities.\n\nProven ability to manage multiple priorities and drive projects to completion in a fast-paced regulated environment.\n\nPreferred Qualifications:\nStrong working knowledge of quality management systems (QMS) and regulated laboratory/manufacturing operations.\n\nExpertise in change control, CAPA management, deviation/nonconformance investigations, and document control processes.\n\nStrong analytical and organizational skills with the ability to manage metrics, trend data, and compliance reporting.\n\nExcellent written and verbal communication skills, including technical writing and audit documentation.\n\nStrong collaboration and stakeholder management skills across cross-functional teams.\n\nProcess improvement mindset with demonstrated success driving operational and quality improvements.\n\nExperience in executing within computerized maintenance/calibration equipment management systems.\n\nExcellent communication skills to influence and collaborate across departments and present technical findings.\n\nLeadership skills to mentor junior engineers and lead cross-functional teams.\n\nStrong project management and organizational skills; able to manage multiple workstreams with competing priorities\n\nPhysical Demands and Work Environment:\nWork performed in office, laboratory, and manufacturing production environments.\n\nRegular interaction with production equipment, requiring PPE such as safety glasses, gloves, lab coats, or cleanroom garments.\n\nFrequent standing, walking, and occasional lifting of 25-30 lbs.\n\nExposure to chemicals, noise, and temperature variations in production areas.\n\nMay require flexible hours, overtime, or weekend work to support production or project deadlines.","description_format":"text","description_chars":5231,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Diagnostic Tests & IVD","Molecular Diagnostics","Precision Medicine"],"lifecycle":[{"event":"open","at":"2026-10-07T18:55:32Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 15 · green card filings: 3","filings_12m":15,"filings_prev_12m":24,"green_card_filings_12m":3,"median_offered_wage_usd":185000,"route":null,"cap_exempt":false,"checked_at":"2026-10-03T21:08:04+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":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":4,"expected_fill_days":55,"reasons":["conf:2","win:early"],"computed_at":"2026-10-12T06:55:09Z"},"pay":null,"html_url":"https://alion.io/job/grail-senior-process-engineer-compliance","json_url":"https://alion.io/job/grail-senior-process-engineer-compliance.json","meta":{"generated_at":"2026-10-12T17:14:42Z","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":27585,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-13T00:00:00Z"}},"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":3593},"rest":"https://alion.io/mcp/rest/get_company?id=3593"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fgrail-senior-process-engineer-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%2Fgrail-senior-process-engineer-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%2Fgrail-senior-process-engineer-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/grail-senior-process-engineer-compliance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fgrail-senior-process-engineer-compliance"}]}