Jigar Patel

About Jigar Patel

SummaryHighly accomplished Associate Director of Engineering with over 17 years of progressive experience in Bio-pharmaceutical Process Automation. Proven leader in digital transformation, consistently delivering operational efficiencies, product quality, and stringent regulatory compliance through advanced automation solutions. I expertly manage complex, multi-million dollar projects from conception to commissioning. My expertise includes designing, implementing, and optimizing sophisticated manufacturing systems that exceed safety, quality, and regulatory standards like GMP and 21CFR Part 11. I build and mentor high-performing engineering teams, fostering collaboration and innovation. My cross-functional approach with IT-OT, Quality, and Maintenance drives impactful solutions and tangible business outcomes. Seeking a challenging leadership role to leverage technical acumen, strategic foresight, and management capabilities, driving innovation and optimizing processes for organizational success.Highlights of QualificationsStrategic Leadership: Co-led the Ignition Community of Practice and served as IT/OT Lead, spearheading the selection and implementation of critical manufacturing execution systems (MES).Project & Program Management: Directed the full lifecycle of large-scale automation projects, including planning, resource allocation, execution, and commissioning, consistently delivering on time and within budget.System Integration & Compliance: Designed and implemented robust system integration architectures, ensuring seamless connectivity and strict adherence to GMP, 21CFR Part 11, and S88 Batch Standards.Team Development & Mentorship: Managed and mentored engineers and contractors, fostering a culture of inclusion, feedback, and empowerment to drive team success and achieve organizational goals.Process Optimization: Evaluated and optimized automated and IT systems, implementing programs that significantly improved performance, resource planning, and capital forecasting.Risk Management: Proactively identified and mitigated risks, ensuring GMP compliance and minimizing disruptions to project timelines and operational costs.Technical SkillsAutomation Systems: DeltaV, Allen-Bradley/Rockwell, Ignition, Wonderware SCADA (Archestra / Intouch / Indusoft Web Studio), OPTO-22, Siemens, PASx MES, POMS, LABX, Lab EquipmentIndustrial Standards: S88 Batch Standards, GMP Standard, 21CFR Part 11, OSHAApplication Software: Windows/Linux Servers, Virtualization, Computer Hardware & Networking, Office Applications, Visio, MATLAB, SQL

Experience

1. Associate Director Engineering

   Merck

   Nov 2023 — Present

   Strategic Leadership & Implementation: Co-led the Ignition Community of Practice and served as the IT/OT Lead. Spearheaded the selection and implementation of PAS-X MES, developing and executing a comprehensive strategy for manufacturing systems and automation that aligned with safety, quality, business, and user requirements. Designed and implemented robust system integration architectures.Project Management & Execution: Developed detailed project plans, including schedules, resource allocation, milestones, and deliverables for automation and manufacturing systems. Directed the design and development of control systems for manufacturing processes and facilities, ensuring accurate installation and compliance with safety, quality, and sustainability objectives. Led new equipment purchases, developed Standard Operating Procedures, Quality Management Systems, and electronic logs.System Integration & Compliance: Integrated automation systems with digital applications, ensuring seamless connectivity across production, quality control, and data management. Coordinated vendor selection with procurement and project teams, ensuring solutions met quality and regulatory standards. Ensured consistency in automation design and execution across facilities, adhering to a uniform approach. Managed audits, CAPAs, SOPs, and change control documentation.Risk Management & Operational Support: Proactively identified and managed risks, ensuring GMP compliance and minimizing disruptions to project timelines and costs. Oversaw commissioning and decommissioning activities and provided critical campaign support. Developed staffing strategies for automation initiatives.

Education

• Hemchandracharya North Gujarat University

  BS, Biomedical and Instrumentation Engineering

  2002 — 2006

• NYU Tandon School of Engineering

  MS, Biomedical Engineering

  2007 — 2008

Skills

• Matlab
• Medical Devices
• Sql
• Linux
• Virtualization
• Plc / Pac Programming
• Cgmp
• Engineering
• R&D
• S88
• Electronics
• Sensors
• 21 Cfr Part 11
• Automation
• Signal Processing
• Delta V
• Rockwell Automation
• Wonderware
• Distributed Systems
• Six Sigma
• Instrumentation
• Electrical
• Gmp
• Project Management
• Biomedical Engineering
• Testing
• Electricians
• Visual Basic
• Win911
• Simulations
• Plc
• Change Control
• Scada
• Quality Assurance
• Programmable Logic Controller (Plc)
• Research and Development (R&D)
• Validation