Engineer

• Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment
• Assist in the design of manufacturing processes, help manage projects, and develop facilities
• Handle FAT, SAT, IQ and OQ documentation development and execute on automated systems projects
• Assist in the development and execution of QMS procedures, ICH Q1 (stability protocols/reports), CFR 21 Part 211, CFR 21 Part 820, ICH Q8, ICH Q9, and ICH Q10
• Conduct investigations and troubleshoot issues related to validation
• Prepare written validation reports

Validation Engineer

Assistant Engineer I

Summer Engineering Intern