Sr. Validation Engineer in Massachusetts

We are seeking a highly experienced Senior CQV (Commissioning, Qualification, and Validation) Engineer to join our team. The ideal candidate will possess a robust background in CQV activities for facilities, utilities, and equipment within regulated industries such as pharmaceuticals, biotechnology, or life sciences. With 7-12 years of hands-on experience, this role requires expertise in project execution, protocol development, regulatory compliance, and cross-functional collaboration to ensure all systems meet current Good Manufacturing Practices (cGMP) standards.

Key Responsibilities:

1. Facilities Qualification:
• Conduct and oversee Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of cleanrooms, HVAC systems, and controlled environments.
• Develop and execute protocols for facility validation including temperature mapping and environmental monitoring.
• Support cleanroom design...