Description

Own the validation lifecycle for plant utilities, facilities, and process equipment, ensuring compliance with regulatory standards.

This role is on-site.

Responsibilities

• Plan, schedule, and execute validation projects for plant utilities and facilities.
• Write and review C&Q plans, study/test protocols, and summary reports.
• Manage protocol execution and review resulting test data.
• Handle protocol deviations, investigations, and corrective action activities.
• Track C&Q documentation and execution against established project timelines.

Required Skills

• Working knowledge of cGMP guidelines and FDA 21 CFR Part 820, 210, and 211.
• Experience with HVAC system commissioning and temperature/humidity mapping.
• Ability to read and comprehend mechanical and electrical engineering drawings.
• Experience with facility qualification and validation activities.
• Strong analytical skills for systematic problem solving.
• Ability to perform both sedentary work and walking within a cGMP manufacturing facility.

Preferred Skills

• Knowledge of ICH guidelines and international regulatory requirements.

Key Skills

Education

ANY GRADUATE