M. Jason Kelly

About M. Jason Kelly

CAI: When you need to meet a higher standardCAI\'s services focus on the delivery, reliability and efficiency of equipment, facilities, and production operations. From manufacturing start-up, to smart operations, asset maintenance and reliability programs, energy use optimization, and regulatory and process consulting, we bring value to your bottom line.Commissioning Agents: Major ServicesFacility Commissioning, Validation, and Start-up• Commissioning and validation planning• Risk assessments• Commissioning project management• Factory acceptance testing• Commissioning procedures, inspection and test forms• Equipment and system installation inspections• Start-up and troubleshooting• Commissioning testing• Validation protocol writing• Protocol field execution and reports• Computer validation, cleaning validation, sterilization validation, product validationLife Cycle Software Development and Validation• Requirements and specification development• Design documentation• Quality assurance/ validation planning• PLC / SCADA programming• Database development• Integration services• Risk assessment• Test planning• GAMP deliverables• Module commissioning• System commissioning• System qualification• System audits• User manual and procedure developmentCompliance Consulting• Auditing and cGMP Compliance Improvement • Preparation for Pre-Approval and General Inspections• 483 and Warning Letter Response Planning and Resolution• Quality and GMP Compliance Policies and Procedures• Quality Manuals and Plans• Quality Systems• Validation Planning and Management• GMP Documentation Review• Preparation and/or Review of Regulatory Filings• 21 CFR Part 11 Compliance• Design Compliance Review• Initial Project Risk Assessments

Experience

1. Validation Engineer Project Manager

   CAI

   Dec 2014 — Present · Research Triangle Park, NC, US

   I help clients accelerate products to market with minimal compliance riskKEY ATTRIBUTES:• Pragmatic problem solver who formulates realistic, actionable solutions• Balances tactical project delivery with strategic stakeholder support• Solid communicator who rapidly grasps and resolves diverse technical issues while keeping an eye on the bottom line• Effective leader who builds strong, cross-functional teams through inclusion, collaboration, and influenceCORE COMPETENCIES:CSV (GAMP5), Risk-Based C&Q (ASTM E2500), Project Management, Data Integrity, Risk Assessments, Team Leadership, Validation, Change Management, Protocol Development/ ExecutionPROJECTS:Validation Lead: DI Remediation for Manufacturing Systems• Provided strategic guidance including risk assessments• Helped client close all CAPAs related to FDA observations on time• Developed technical and procedural controls to ensure data integrityCSV Lead: Global, Enterprise CMMS Deployment• Part of team that achieved on-time delivery of qualified CMMS (Maximo in the cloud) at 7 manufacturing sites in 3 countries• Implemented an efficient, risk- and GAMP5-based CSV approach• Served as Global CSV Lead for Client’s Organization advising on all aspects related to operating and maintaining the validated statePrincipal Lead: Laboratory C&Q• Led team responsible for Commissioning and Qualification of 2 large laboratories (Analytical & Micro,>330 instruments and sq. ft) at a greenfield blood fractionation facility• Developed and executed IV, OV, IQ, & OQ protocolsCSV Engineer: Infrastructure Qualification• Developed specifications and protocols to qualify S95-Compliant Manufacturing Infrastructure for manufacturing expansion• Implementation included Nutanix, multiple SCADA skids, historian, integrated local & cloud services Maintenance & Reliability Engineer: QA Laboratory• SAP-based Computerized Maintenance Management System (CMMS)• Prepared PM plans for lab utilities & equipment

Education

• North Carolina State University

  Master of Science (M.S.), Chemical Engineering

  1998 — 2001

• Case Western Reserve University

  Bachelor of Science (B.S.), Chemical Engineering

  1994 — 1998

• North Carolina State University

  Doctor of Philosophy (Ph.D.), Chemical Engineering

  2001 — 2005

• Case Western Reserve University

  Bachelor of Science (B.S.), Chemistry

  1994 — 1998

Skills

• Scientific Writing
• Chemistry
• Catalysis
• Microbial Fermentation
• Gmp
• Atomic Layer Deposition
• Cvd
• Characterization
• Proposal Writing
• Spectroscopy
• Iq / Oq / Pq
• Reaction Engineering
• Project Management
• Materials Science
• Gas and Liquid Chromatography (Gc / Lc)
• Semiconductor Process Technology
• Heterogeneous Catalysis
• Fermentation
• Nanoparticles
• Thin Films
• Validation
• Cross-Functional Collaborations
• Technical Presentations
• Experimentation
• Design of Experiments
• Project Planning
• Xps
• Sputtering
• Ftir
• Electronic Materials
• Process Validation
• Plasma Science
• Biotechnology
• Research and Development (R&D)
• Pharmaceutical Manufacturing
• Chemical Engineering
• Nanotechnology
• Commissioning
• Surface Chemistry
• Reactor Design