Mohnish sharma

I am writing to express my strong interest in the contract Validation Engineer position that you have advertised. With over 5+ years of experience in equipment qualification and quality assurance, I believe I would be a valuable addition to your team.

I am currently working as a Validation Engineer at Pfizer in Kalamazoo, MI where I have been responsible for compiling and analyzing validation data, preparing protocols, reporting and making recommendations for changes and improvements, and maintaining appropriate validation documentation and files. Prior to this, I worked as a Validation Engineer at Resilience in Allston, MA, and at Aavis Pharmaceutical in Hoschton, GA.

I hold a Master's degree in industrial engineering from the University of Texas at Arlington and a Bachelor's degree in mechanical engineering from the University of Mumbai in India. I am excited about the opportunity to apply my skills and knowledge to new challenges and look forward to discussing my application further.

Thank you for considering my application. I look forward to the opportunity to further discuss my qualifications with you.
 

Experienced Validation Specialist in the medical device and pharmaceuticals industry with a strong background in
validation of facilities, utilities, equipment’s and also have a Validation Subject Matter Expert (SME). Proficient in
navigating FDA regulations and GxP standards to ensure compliance. Skilled in developing and executing CQV plans,
protocols, and reports for facilities, utilities, and equipment. Specialized in implementing single-use technology solutions
and tailoring CQV strategies for cell therapy and gene therapy manufacturing. Proficient in managing equipment
lifecycle documents and providing technical support during regulatory inspections. Detail-oriented with expertise in SOP
development, deviation management, and change control assessments.

Master’s in industrial engineering, UNIVERSITY OF TEXAS AT ARLINGTON, Texas
Bachelor’s in mechanical engineering, UNIVERSITY OF MUMBAI