Description

You will own validation activities for equipment, laboratory processes, and software applications to ensure compliance with regulatory standards.

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.
• Prepare and revise validation protocols and procedures to maintain compliance with FDA and cGMP standards.
• Ensure all laboratory equipment and processes adhere to FDA rules and regulations.

Required Skills

• Experience with FDA and cGMP standards.
• Hands-on experience with IOPQ (Installation, Operation, and Performance Qualification).
• Ability to analyze validation data and draft formal reports.
• Experience validating software interfaces for R&D or pharmaceutical equipment.
• Master’s degree in Engineering, Technology, Analytical Science, or a related field.
• 3+ years of professional experience.
• Willingness to travel to client locations throughout the USA.

Key Skills

Education

Any Graduate