Harshal Patel
About Harshal Patel
Harshal Patel is the Lead Validation Engineer for Process/Cleaning at Alkermes in Wilmington, Ohio, with extensive experience in validation across multiple industries.
Current Position at Alkermes
Harshal Patel currently holds the position of Lead Validation Engineer- Process/Cleaning at Alkermes, based in Wilmington, Ohio. In this role, he is chiefly responsible for overseeing validation processes related to both equipment and cleaning methods.
Previous Experience at West-Ward Pharmaceuticals
From 2015 to 2017, Harshal Patel worked at West-Ward Pharmaceuticals as an Engineer III in Cleaning Validation. During his tenure, he worked on developing and implementing cleaning validation protocols and ensuring that the cleaning processes met regulatory compliance.
Consultancy Role at Merck
Between 2014 and 2015, Harshal Patel served as a Validation Consultant III at Merck. For nearly ten months, he provided critical validation services which included the preparation and review of validation protocols to support various validation activities.
Educational Background
Harshal Patel earned a Master's degree in Pharmaceutical Manufacturing from the Stevens Institute of Technology, where he studied from 2009 to 2011. Prior to that, he completed a Bachelor of Pharmacy (B.PHARM) at B.M SHAH, spanning from 2004 to 2008.
Expertise and Specialization
Harshal Patel has extensive experience in several forms of validation, including equipment, process, cleaning, computer systems (LIMS), and utility validation. He specializes in preparing Standard Operating Procedures (SOPs), validation protocols, and summary reports. Additionally, he conducts root cause analysis and implements Corrective and Preventive Actions (CAPA) as well as performs risk analysis and safety assessments.