Description

You will manage validation processes for equipment, laboratory tools, and software applications within a regulated environment.

Responsibilities

• Execute validation plans, requirement specifications, and protocols including installation, operation, and performance qualification (IOPQ).
• Analyze validation data and prepare technical reports and standard operating procedures.
• Validate computer software applications and equipment interfaced with pharmaceutical or R&D hardware.
• Ensure all equipment and processes remain compliant with FDA and cGMP standards.
• Prepare and revise validation protocols and procedures as required.

Required Skills

• Master’s degree in Engineering, Technology, Analytical Science, or a related field.
• 1+ years of experience in validation engineering.
• Direct experience with FDA and cGMP regulatory standards.
• Hands-on experience executing IO/PQ protocols.
• Ability to validate software applications interfaced with laboratory equipment.
• Proficiency in preparing standard operating procedures (SOPs).
• Experience in equipment and process validation.

Key Skills

Education

Master’s degree in Engineering