GeneFab
Senior Manufacturing Engineer
Alameda, CA · Senior · Full-time
Sponsorship not specifiedDetected 85 days ago
CadenceRoboticsGMPCRISPRCommunicationCollaborationWritingSCADA
About the role
- The 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 is a high-visibility, high-impact individual contributor role.
- This position is offered as a contract engagement with eligibility for conversion to full-time employment based on performance, business needs, and mutual alignment.
Responsibilities
- Lead and support design, evaluation, selection and implementation of production technologies and equipment that support highly efficient production of Cell and Gene Therapies.
- Lead the evaluation, selection, and implementation of an electronic systems such as batch record (EBR) platform to replace paper batch records across all manufacturing processes.
- Develop 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.
- from URS, basis of design/risk assessment, detailed design, implementation, commissioning and qualification.
- Own the relationship with digital system and integration middleware vendors, managing contracts, upgrades, issue resolution, and roadmap alignment.
- Develop and maintain system-level documentation including user requirements specifications, system configuration documents, and periodic review reports.
- Build the data infrastructure that enables continued process verification (CPV), ensuring process parameters, quality attributes, and environmental data are consolidated and accessible for statistical trending.
- Responsible for equipment and systems end to end; from URS, basis of design/risk assessment, detailed design, implementation, commissioning and qualification.
- Partner with MSAT to define data extraction and aggregation workflows from EBR, LIMS, and historian systems to support CPV analysis and reporting.
- Design and implement dashboards and automated reporting tools for real-time manufacturing performance visibility.
Requirements
- Minimum 8+ years of progressive experience in pharmaceutical, biopharmaceutical, or cell/gene therapy manufacturing environments.
- 3+ 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.
- Strong understanding of 21 CFR Part 11, ALCOA+ data integrity principles, GAMP 5 computer system validation, and GMP regulatory expectations for electronic records.
- Hands-on experience with equipment data integration, including familiarity with OPC-UA, APIs, database connectivity, network architecture, and/or middleware platforms.
- Experience serving as a system owner or system administrator for validated computerized systems in a GMP environment.
- Demonstrated ability to work cross-functionally with Manufacturing, Quality, Validation, IT, and Facilities teams.
- Experience with CGT-specific manufacturing equipment required.
- Demonstrated ability to operate with a high degree of independence, define scope, manage competing priorities, and deliver results in a fast-paced, dynamic environment.
- Bachelor's degree in Engineering (Biomedical, Chemical, Electrical, Mechanical), or related field required; advanced degree (M.S. or Ph.D.) preferred.
- Strong technical writing capability and excellent cross-functional communication and collaboration skills.
Nice to have
- Bachelor's degree in Engineering (Biomedical, Chemical, Electrical, Mechanical), or related field required
- advanced degree (M.S. or Ph.D.) preferred.
- Experience in cell therapy, gene therapy, or advanced therapy manufacturing environments preferred.
- Experience 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.
- Experience supporting process validation lifecycle activities, BLA preparation, or regulatory inspection readiness preferred.
Benefits
- Ensure comprehensive data backup coverage across all instruments, (including those not natively connected to network backup systems such as UniTrends)
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This listing is sourced directly from GeneFab's careers page and normalized into a canonical job model.