Senior Manufacturing Engineer

Responsibilities:

Lead 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.
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.
Establish 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.
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.
Responsible for equipment and systems end to end; from URS, basis of design/risk assessment, detailed design, implementation, commissioning and qualification.   
Evaluate 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.
Ensure all implemented systems comply with 21 CFR Part 11, ALCOA+ data integrity principles, and applicable GAMP 5 guidelines.
Act 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.
Own periodic review cadence, audit trail reviews, user access management, and health monitoring system.
Manage 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.
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.
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.
Ensure comprehensive data backup coverage across all instruments, (including those not natively connected to network backup systems such as UniTrends)
Support 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).
Contribute to regulatory inspection readiness by maintaining inspection-ready system documentation, audit trails, and access control records.

Qualifications

Bachelor’s degree in Engineering (Biomedical, Chemical, Electrical, Mechanical)  , or related field required; advanced degree (M.S. or Ph.D.) preferred.
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 in cell therapy, gene therapy, or advanced therapy manufacturing environments preferred.
Experience with CGT-specific manufacturing equipment required.
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.
Strong technical writing capability and excellent cross-functional communication and collaboration skills.
Demonstrated ability to operate with a high degree of independence, define scope, manage competing priorities, and deliver results in a fast-paced, dynamic environment.