Kevin Daubert

About Kevin Daubert

Accomplished Leader with cGMP experience in the diagnostics, medical device, and pharmaceutical industries. Providing Engineering and Technical Operations leadership to the Roche Branchburg manufacturing work streams through a team of subject matter and technical experts (100), advancing the Roche Branchburg Engineering & Technical Operations Team\'s mission to be a strategic business partner by providing quality, value-added, innovative solutions for Roche capital investments and sitewide Operations. Responsible for sitewide programs including Engineering, Instrument Calibration, Equipment and Facility Qualification and Instrument/Equipment Management. Member of the Branchburg site Leadership Team. Additional responsibilities include capital expenditure oversight and governance for manufacturing operations. Proven change agent. Ability to manage projects of varied scope, produce deliverables on time and on budget, and successfully bridge the gap between efficiency and compliance using an agile approach to project execution. Exceptional written and verbal communication skills facilitate the creation of an inspired, dedicated and results-driven team.

Experience

1. Senior Director, Engineering & Technical Operations

   Roche

   Nov 2025 — Present · Branchburg, NJ, US

   Lead the Engineering & Technical Operations teams (100) of technical professionals responsible for supporting IVD manufacturing value streams, including specification, procurement, installation & commissioning of automated filling & packaging equipment, implementation of process improvements, equipment upgrades and manage scheduled/unscheduled maintenance. Additional team responsibilities include oversight of sitewide programs for instrument calibration, equipment and facility qualification, and instrument and equipment management. Additional expertise and support includes package development, plastics processing expertise and oversight of technical documentation (e.g. change management requests, specifications, product launch documentation, technical transfer, filling & packaging records and SOP’s). Project-manage engineering activities for large-scale projects. Justify capital expenditure for filling & packaging operations and maintain funding/spend for same. Maintain department budgets. Oversee and ensure completion of associated department training, technical SOP creation/revision, nonconformance investigations and CAPA.Interaction and knowledge sharing with Roche counterparts in Europe and Asia on supplier management and oversight for primary (plastics) and secondary (paper board) packaging. Activities include evaluating customer complaints, executing RCI, executing engineering studies, specification evaluation and general oversight to hold suppliers accountable.Supported technical transfers to Roche suppliers for filling, packaging, automated assembly of and laser welding of reagent vessels, and automated assembly of LIAT framing and cap processes.

Education

• Kean University

  B.S., Industrial Technology

• New Jersey Institute of Technology

  M.S., Engineering Management

Skills

• Validation
• 21 Cfr Part 11
• Quality Assurance
• Gmp
• Cross-Functional Team Leadership
• Iso 13485
• Calibration
• Manufacturing
• Gxp
• Change Control
• Engineering Change Management
• Biotechnology
• Computer System Validation
• Pharmaceutical Industry
• Sop
• Maintenance Management
• Fda
• Project Management
• Quality System
• V&V
• Corrective and Preventive Action (Capa)
• Project Engineering
• Medical Devices
• Instrumentation
• Capa
• Engineering Management