SR. VALIDATION ENGINEER

As a Sr. Validation Engineer at CMIC CMO USA Corporation in Cranbury, NJ, your role involves utilizing pharmaceutical science analytics to author validation protocols in compliance with cGMP/FDA standards. You will be responsible for planning, managing, and executing start-up, commissioning, and validation of new pharmaceutical equipment. Additionally, you will draft and implement qualification protocols, resolve deviations and CAPA, prepare validation reports, develop SOPs for manufacturing and packaging equipment, as well as write test protocols. **Key Responsibilities:** - Author validation protocols in compliance with cGMP/FDA standards - Plan, manage, and execute start-up, commissioning, and validation of new pharmaceutical equipment - Draft and implement qualification protocols - Resolve deviations and CAPA - Prepare validation reports - Develop SOPs for manufacturing and packaging equipment - Write test protocols **Qualifications Required:** - Masters (or foreign equivalent degree) in Pharmaceutical Sciences or related field - Knowledge of preparation and review of process validation and cleaning validation protocols - Experience in review and execution of IQ/OQ, deviation investigations, root cause analysis, and CAPA Please note that CMIC CMO USA Corporation is a part of CMIC HOLDINGS Co., Ltd., established in 1992. The company has a significant number of employees and a strong presence in the pharmaceutical industry. If you possess the required qualifications and experience, please contact Gabrielle Gillespie at gabrielle-gillespie@cmiccmousa.com to apply for this full-time position.,