New Brunswick, NJ 08901
- Manage routine calibration, validation documentation and monitoring systems.
- Generate and execute all Validation protocols (IQ/OQ/PQ) of all site equipment including production equipment, product storage, utilities (as applicable) and other related systems in an FDA regulated environment.
- Assess the impact of changes to validated systems and write protocols to achieve and maintain cGMP compliance.
- Review of change control, calibration, preventative and correct maintenance documentation for equipment to assure that all remain in a validated state.
- Responsible for managing all aspects of equipment cleaning validation and environmental monitoring.
- Write and revise applicable Standard Operating Procedures (SOPs) as required.
- Responsible for the validation, calibration, maintenance and upkeep of equipment required for the validation program.
- Perform other duties as needed.