Senior Validation Engineer

Role Summary

Senior Validation Engineer responsible for developing test protocols, preparing equipment, documenting test results, and maintaining records for installation, operation, performance qualification, and requalification/revalidation protocols for manufacturing equipment and systems using established validation standards and procedures. The role also includes assisting in process and cleaning validations to ensure compliance with cGMP expectations.

Responsibilities

• Prepares all protocols and reports for validation and revalidation work
• Coordinates and executes validation studies for equipment including autoclaves, glass washers, depyrogenation ovens, utility systems (purified water, WFI water, gas systems, clean steam), incubators, clean rooms, freezers, and cold rooms
• Performs testing using standard concepts, practices and procedures of the cGMP process
• Reviews and summarizes equipment history files to assess the validated state of equipment
• Makes adjustments to equipment or processes that require improvement and/or repair
• Performs a variety of validation tasks and projects outside classical validation tasks and apply diverse engineering development skills to increase operational efficiencies and product quality, and decrease costs as assigned by supervisor and/or designee
• Assist in process and cleaning validation as required
• Participate in the creation and/or review of Standard Operating Procedures (SOPs) for system projects

Qualifications

• Preferred: 2-5 years of experience validating cGMP systems

Skills

• Previous validation experience in the Pharmaceutical/Medical Device industry
• Be familiar with aseptic processing and clean room operations
• Able to work independently, possess strong organizational skills
• Have good written and verbal communication skills
• Highly motivated and creative with strong hands-on validation skills
• Proficiency with Kaye Validator programming, validation of test equipment, and technical writing skills

Education

• Bachelor’s degree in a relevant field