Hitesh Malik
About Hitesh Malik
Hitesh Malik is a Sr. Validation Engineer at Bristol Myers Squibb in the Greater Seattle Area, with extensive experience in validation analysis and regulatory requirements.
Company
Hitesh Malik is currently employed at Bristol Myers Squibb, based in the Greater Seattle Area. He holds the position of Sr. Validation Engineer at the pharmaceutical company.
Title
Hitesh Malik serves as a Sr. Validation Engineer. His role involves ensuring that systems and processes meet required specifications and regulatory standards.
Education and Expertise
Hitesh Malik has a deep understanding of regulatory requirements such as SOX, 21 CFR 11, and Annex 11. He is experienced in statistical process control and root cause analysis, holds expertise in Six Sigma and process optimization, and is proficient with multiple software tools including MS Office Suite (MS Project, Access, Word, PowerPoint), Workday, JIRA, HP ALM, JMP, Minitab, Excel, and Tableau. He also possesses knowledge in programming languages like R and SQL.
Background
Hitesh Malik has built a substantial career with significant roles across various pharmaceutical companies. He was a Sr. Validation Analyst (Consultant) at Sanofi in Bridgewater, NJ from 2017 to 2019, a Senior Validation Analyst - Consultant at Teva Pharmaceuticals in the Greater Philadelphia Area in 2017. Additionally, he has worked as a Validation Analyst - Consultant at Endo Pharmaceuticals in Malvern, PA (2016-2017), a Quality and Compliance Engineer - Consultant at Allergan in Rockaway, NJ for four months in 2016, and as a Validation Engineer - Consultant at Quotient Sciences in Boothwyn, PA in 2015-2016.
Achievements
Through his career, Hitesh Malik has demonstrated proficiency in developing technical specifications, working with cross-functional teams, training new team members on existing business processes, and managing multiple projects under tight deadlines. His experience spans critical validation roles at leading pharmaceutical companies.