Process Validation Engineer

Responsibilities

Performing process, equipment, and software validation activities including, but not limited to, gathering historical data for product manufacture, analyzing data using statistical principles, writing validation protocols and reports, GDP review of data and reports, and final approval of validation protocols, reports, and deviations.

May interact in cross-functional teams including Reagent Manufacturing Engineers and Chemists, Research and Development, and Quality Assurance Validation Engineers.

May be responsible for leading teams to perform validation activities or perform as a member of the team.

Simultaneously work on multiple projects.

Requirements

• Education: bachelor’s degree
• Experience (preferred):
• Experience in a quality related function in a medical device or other FDA regulated environment. Previous work with IVD reagent products under GMP conditions
• Process validation (IQ, OQ, PQ) and test method validation experience
• Software validation experience
• Knowledge of general reagent manufacturing processes, antibody purification and conjugation, flow cytometry
• Certified Quality Engineer
• Six Sigma Certification
• Knowledge of applicable regulatory requirements including ISO13485, ISO14971, ISO9001, quality systems regulations (21 CFR: 820)
• Training in statistics.
• Experience with Minitab or other statistical software, MS Excel, and MS Word required