Validation Engineer

GxP Associates is looking to hire Validation Engineers with experience in pharmaceutical or medical device manufacturing environments. The ideal candidate will be responsible for supporting equipment validation, executing qualification protocols, and ensuring compliance with regulatory standards such as GMP and FDA requirements.

Responsibilities:

• Author, review, and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols
• Support Performance Qualification (PQ) activities for manufacturing and packaging systems
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) activities
• Support equipment installation, commissioning, and validation activities
• Validate automated assembly and packaging systems used in manufacturing
• Conduct challenge testing for alarms, safety interlocks, and fault recovery scenarios
• Document deviations, discrepancies, and validation reports
• Ensure compliance with FDA regulations, GMP standards, and 21 CFR Part 11
• Collaborate with Quality Assurance, Engineering, and cross-functional teams during validation activities

Requirements:

• Strong experience with IQ / OQ / PQ validation protocols
• Experience with equipment qualification and commissioning
• Knowledge of FAT and SAT activities
• Experience in GMP-regulated pharmaceutical or medical device environments
• Strong technical documentation and validation report writing skills