
Gautam Patel
I am an experienced Validation Manager in the pharmaceutical industry, specializing in Cell and Gene Therapy (CGT) manufacturing... | Langhorne, Pennsylvania, United States
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Gautam Patel’s Location Langhorne, Pennsylvania, United States
Gautam Patel’s Expertise I am an experienced Validation Manager in the pharmaceutical industry, specializing in Cell and Gene Therapy (CGT) manufacturing equipment, utilities, facilities and process qualifications. I have a proven track record of establishing validation policies, procedures, and strategies that align with industry regulations and quality standards. At Catalent Pharma Solution , I lead the development and implementation of comprehensive validation programs. Collaborating with cross-functional stakeholders, I integrate Equipment/Facility/Utility Qualification into Catalent's Validation Program. As a Subject Matter Expert (SME), I ensure compliance with FDA and other regulatory requirements during client and regulatory audits. In my role, I effectively manage the CQV team and contractors, overseeing validation activities. I excel at reviewing Change Controls , providing guidance, and identifying improvement opportunities. With a customer-focused approach, I navigate complex issues in fast-paced environments, ensuring smooth progress of multiple client projects through the qualification process. Previously, as a Sr Validation Contractor at Spark Therapeutics and Compliance Technology Group, I developed validation protocols, executed validation activities, and supported manufacturing facility launches. I conducted qualifications for various equipment using industry-standard tools and instruments. I hold a Master's degree in Pharmaceutical Engineering from the New Jersey Institute of Technology and a Bachelor's degree in pharmacy from Gujarat University. As a Certified Six Sigma Green Belt with training in project management and operational excellence, I prioritize quality and process improvement. I am dedicated to the growth and development of my team, fostering collaboration, and contributing to organizational success. If you seek a results-oriented Validation Manager with expertise in the pharmaceutical industry, let's connect. I am eager to explore how my skills and experience can add value to your organization.
Gautam Patel’s Current Industry Genscript Probio
Gautam
Patel’s Prior Industry
Nutra Med Packaging
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Amneal Pharmaceuticals
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Zimmer Biomet
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Ctg
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Spark Therapeutics
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Erytech Pharma
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Catalent Pharma Solutions
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Genscript Probio
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Work Experience

Genscript Probio
Senior Validation Manager
Thu Feb 01 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Catalent Pharma Solutions
Validation Manager
Sun May 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jun 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Erytech Pharma
Validation Manager
Tue Mar 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun May 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Spark Therapeutics
Senior Validation Specialist at Yoh
Sun Jul 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Mar 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Ctg
Validation Specialist II, Client: Celgene
Wed Nov 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jul 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Ctg
Validation Specialist II at Wuxi AppTec
Sat Aug 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Nov 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Zimmer Biomet
Process Validation Engineer
Sat Mar 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Aug 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Amneal Pharmaceuticals
Validation Engineer
Sat Sep 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Mar 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Nutra Med Packaging
Quality Specialist
Thu Mar 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Sep 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)