{"id":768384,"url":"https://alion.io/job/genefab-senior-manufacturing-engineer","title":"Senior Manufacturing Engineer","company":{"id":674418,"name":"GeneFab","domain":"genefab.com","url":"https://alion.io/company/genefab","size_band":"1-10","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":["Alameda, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":72,"max":86,"currency":"USD","period":"hour","gross":null,"usd_annual":172000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"Benchling","optional":false},{"name":"GMP","optional":false},{"name":"InfluxDB","optional":false},{"name":"LIMS","optional":false},{"name":"OPC UA","optional":false},{"name":"Time Series","optional":false}],"status":"live","first_seen_at":"2026-04-28T00:56:01Z","employer_posted_date":"2026-04-28","last_verified_at":"2026-11-08T06:37:09Z","board_verified":true,"closed_at":null,"days_open":194,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":193},"description":"GeneFab is seeking a Senior Manufacturing Engineer to lead the identification, implementation, and management of production technology and digital infrastructure across our GMP manufacturing operations. This role will serve as the primary driver of GeneFab’s deployment of innovative technologies (internally developed and integration of external) and it’s transition to digital systems (including electronic batch records, process data historians),equipment data integration, and lifecycle management.\nThe Senior Manufacturing Engineer will act as system owner for critical and specialized manufacturing equipment and computerized systems, owning the lifecycle of critical equipment and systems, from acquisition to offboarding. This role will also support commercial readiness activities, contributing to continued process verification infrastructure and regulatory inspection preparedness as GeneFab advances through later-stage clinical and commercial readiness.\nThis is a high-visibility, high-impact individual contributor role. The ideal candidate combines deep GMP manufacturing knowledge with hands-on experience implementing equipment and digital systems in a regulated environment, and thrives in a fast-paced, entrepreneurial setting where they will build and integrate capabilities from the ground up.\nThis position is offered as a contract engagement with eligibility for conversion to full-time employment based on performance, business needs, and mutual alignment. GeneFab is committed to investing in high-performing contributors and views this role as a long-term addition to the organization.\nResponsibilities:\nLead and support design, evaluation, selection and implementation of production technologies and equipment that support highly efficient production of Cell and Gene Therapies. This includes novel unit operations and process interface equipment, robotics, physical and digital AI, and other related technologies.\nLead the evaluation, selection, and implementation of an electronic systems such as batch record (EBR) platform to replace paper batch records across all manufacturing processes.\nEstablish a process data historian (e.g., AVEVA PI, InfluxDB) to capture and store time-series process and environmental data from manufacturing equipment and cleanroom monitoring systems.\nDevelop and execute the equipment data integration strategy, establishing connectivity between GMP instruments (e.g., Miltenyi Prodigy, Cytiva Xuri/XDR/AKTA, Fresenius Kabi Lovo, Sepax, Vi-CELL BLU, NucleoCounter, CryoMed controlled-rate freezers, etc…) and centralized data systems.\nResponsible for equipment and systems end to end; from URS, basis of design/risk assessment, detailed design, implementation, commissioning and qualification. \nEvaluate and deploy integration solutions including OPC-UA connections, data bridge PCs, network file shares, and middleware platforms (e.g., Scitara, Tetra Science) based on instrument connectivity capabilities.\nEnsure all implemented systems comply with 21 CFR Part 11, ALCOA+ data integrity principles, and applicable GAMP 5 guidelines.\nAct as system owner for critical and specialized manufacturing equipment from a data and systems perspective, ensuring equipment data outputs are captured, backed up, and accessible for process monitoring and regulatory purposes.\nOwn periodic review cadence, audit trail reviews, user access management, and health monitoring system.\nManage equipment lifecycle from a systems perspective: lead new equipment implementation and commissioning of data connectivity, oversee system retirement and data archival. Physical maintenance, calibration, and qualification remain with Facilities, Validation, and/or Metrology.\nOwn the relationship with digital system and integration middleware vendors, managing contracts, upgrades, issue resolution, and roadmap alignment.\nDevelop and maintain system-level documentation including user requirements specifications, system configuration documents, and periodic review reports.\nBuild the data infrastructure that enables continued process verification (CPV), ensuring process parameters, quality attributes, and environmental data are consolidated and accessible for statistical trending.\nPartner with MSAT to define data extraction and aggregation workflows from EBR, LIMS, and historian systems to support CPV analysis and reporting.\nDesign and implement dashboards and automated reporting tools for real-time manufacturing performance visibility.\nEnsure comprehensive data backup coverage across all instruments, (including those not natively connected to network backup systems such as UniTrends)\nSupport commercial readiness activities by ensuring digital systems and data infrastructure are in place to support process validation lifecycle stages, including Stage 3 (continued process verification).\nContribute to regulatory inspection readiness by maintaining inspection-ready system documentation, audit trails, and access control records.\nQualifications\nBachelor’s degree in Engineering (Biomedical, Chemical, Electrical, Mechanical) , or related field required; advanced degree (M.S. or Ph.D.) preferred.\nMinimum 8+ years of progressive experience in pharmaceutical, biopharmaceutical, or cell/gene therapy manufacturing environments.\n3+ years of direct experience implementing or managing production technology and digital manufacturing systems such as EBR, LIMS, MES, data historians, or SCADA in a GMP-regulated setting.\nStrong understanding of 21 CFR Part 11, ALCOA+ data integrity principles, GAMP 5 computer system validation, and GMP regulatory expectations for electronic records.\nHands-on experience with equipment data integration, including familiarity with OPC-UA, APIs, database connectivity, network architecture, and/or middleware platforms.\nExperience serving as a system owner or system administrator for validated computerized systems in a GMP environment.\nDemonstrated ability to work cross-functionally with Manufacturing, Quality, Validation, IT, and Facilities teams.\nExperience in cell therapy, gene therapy, or advanced therapy manufacturing environments preferred.\nExperience with CGT-specific manufacturing equipment required.\nExperience with specific platforms such as (but not limited to) Apprentice.io, MasterControl, PAS-X (EBR), LabVantage, LabWare, or Benchling (LIMS), and/or AVEVA PI or InfluxDB (historian) preferred.\nExperience supporting process validation lifecycle activities, BLA preparation, or regulatory inspection readiness preferred.\nStrong technical writing capability and excellent cross-functional communication and collaboration skills.\nDemonstrated ability to operate with a high degree of independence, define scope, manage competing priorities, and deliver results in a fast-paced, dynamic environment.","description_format":"text","description_chars":6796,"description_truncated":false,"requirements":{"experience_years_min":8,"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":["Synthetic Biology","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-09-11T20:42:14Z"}],"visa":[],"liveness":{"score":6,"band":"cold","label":"Long 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