Pratik Patel
PHARMACEUTICAL ENGINEERING MANAGEMENT PROFESSIONAL
Buffalo
Summary
Experienced professional with extensive background in pharmaceutical manufacturing, specializing in solid, oral liquid, and injectable technologies. Demonstrated success in team management and capital project oversight. Excited to apply skills and experience to enhance your team and achieve significant results.
Overview
21
21
years of professional experience
11
11
years of post-secondary education
Work History
Engineering Manager
FRESENIUS KABI USA LLC
06.2021 - Current
- Led Engineering project teams and Subject Matter Expert (SME) technical support initiatives to drive project success.
- Oversaw CAPEX budgeting and project management to ensure financial efficiency and strategic alignment.
- Directed the design and construction of new and renovated facilities, enhancing operational capabilities.
- Reviewed compliance documentation, including SOPS, CPAs, FAT, SAT, IOQ, and PPQ, to maintain high standards of quality and safety.
- Ensured compliance with cGMP, OSHA, and DEC regulations, fostering a culture of safety and quality.
- Managed daily engineering support functions, streamlining operations and driving continuous improvement.
- Enhanced overall team productivity with continuous training and mentoring of junior engineers.
- Improved engineering processes by streamlining workflows and implementing efficient project management techniques.
Engineering Manager
AMNEAL PHARMACEUTICALS
12.2014 - 06.2021
- Led a Maintenance & Engineering team in a 100,000 sq ft manufacturing facility, optimizing performance across multiple manufacturing and packaging lines.
- Championed the successful completion of a new FDA-approved 350,000 sq ft pharmaceutical manufacturing facility, achieving LEED certification.
- Spearheaded the installation and integration of Serialization (Track & Trace) Systems across 24 packaging lines in 5 facilities, ensuring regulatory compliance and operational efficiency.
- Directed capital projects, expertly managing the entire project lifecycle from Project Charter to Contract closure and Go Live for Equipment installation, Automation, BMS, and Construction.
- Implemented strategic, innovative solutions to align with and drive company objectives and targets.
Electronic Engineer
AMNEAL PHARMACEUTICALS
10.2009 - 12.2014
- Developed and executed qualification protocols, ensuring compliance.
- Performed electronic troubleshooting, optimizing equipment for production.
- Coordinated successful installations of manufacturing control systems.
- Maintained SOPs, Change Controls, NOI assessments, Corrective Actions and deviations to be compliant with the cGMP requirements.
Electronic Engineer
AMBA SALES & SERVICES
11.2004 - 12.2005
- Engineered automated control panels for pharmaceutical cGMP applications.
- Revamped and optimized pre-owned equipment controls for efficiency.
Education
Master of Science - Electrical And Electronic
California State University
Sacramento, CA 05.2001 - 01.2009
Bachelor of Science - Electrical, Electronics And Communications Engineering
Gujarat University
Gandhinagar, India 05.2001 - 01.2005
Skills
- PMP CERTIFIED PROFESSIONAL
- CAPEX MANAGEMENT
- FACILITIES AND CRITICAL UTILITIES
- MANUFACTURING ENGINEERING
- PHARMA MFG CONSTRUCTION
- ENGINEERING MEP DESIGN
- DRAWINGS
- OPERATIONAL EXCELLENCE
- PACKAGING AND SERIALIZATION
- CGMP LIFECYCLE DOCUMENTS
- AUTOMATION AND CONTROLS
- FORM, FILL, INSPECTION, PACK LINES
Websites
Timeline
Engineering Manager
FRESENIUS KABI USA LLC
06.2021 - Current
Engineering Manager
AMNEAL PHARMACEUTICALS
12.2014 - 06.2021
Electronic Engineer
AMNEAL PHARMACEUTICALS
10.2009 - 12.2014
Electronic Engineer
AMBA SALES & SERVICES
11.2004 - 12.2005
Master of Science - Electrical And Electronic
California State University
05.2001 - 01.2009
Bachelor of Science - Electrical, Electronics And Communications Engineering
Gujarat University
05.2001 - 01.2005
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