Method Development Engineer - validation

Company Overview: We are an OTC Drug and Cosmetics manufacturer with an Employee Stock Ownership Plan (ESOP, seeking a dedicated and experienced Analytical ChemistMethods Engineer to join our team.Key Responsibilities:·Design, develop, validate, and verify analytical methods for testing raw materials, finished products, stability, and process validation.·Conduct analysis of Active Pharmaceutical Ingredients (APIs), excipients, and finished drug products according to company SOPs, cGMPs, GLPs, GDPs, and FDADEAOSHA regulations.·Develop and execute protocols, reports, and test methods related to raw material and finished product testing.·Provide technical expertise to support laboratory investigations and method transfers between facilities.·Operate and troubleshoot routine laboratory equipment, including Gas Chromatography (GC), Liquid Chromatography (LCHPLCUPLC), and Inductively Coupled Plasma (ICP).·Utilize Empower software for data analysis and method development.·Ensure compliance with FDA Regulations, USPNF monographs, and ICH guidelines.Required Qualifications and Skills:·BS degree in analytical chemistry, organic chemistry, biochemistry, or food science with coursework in analytical chemistry.·Minimum of 3 years of laboratory experience in method development, validation, verification, and transfer activities for pharmaceutical raw materials and finished products.·Proficiency in operating laboratory instrumentation and conducting statistical analysis.·Strong knowledge of USP, FDA, and ICH guidelines.·Effective communication skills and ability to work independently with minimal supervision.·Proven ability to organize projects and complete tasks in a timely manner.Preferred Skills:·Proficiency in Empower software.·Self-motivated with the ability to work independently and within a team.·Strong organizational skills and attention to detail.Education:·Minimum requirement of a BS degree in analytical chemistry, organic chemistry, or biochemistry.

Created: 2025-02-21