Title: Equipment Validation Engineer

Location : Cambridge, MA (Onsite)

We are looking for an Equipment Validation Engineer with 5+ years of experience in pharmaceutical manufacturing . In this role, you’ll be responsible for ensuring the qualification and validation of manufacturing equipment, while ensuring compliance with FDA and cGMP standards.

Key Responsibilities :

• Lead IQ, OQ, PQ protocols for equipment qualification.
• Ensure compliance with FDA 21 CFR Part 211 , cGMP , and industry regulations.
• Develop and review validation documentation (protocols, reports, SOPs).
• Collaborate with engineering and quality assurance teams for system optimization.

Requirements :

• 5+ years of experience in equipment validation within the pharmaceutical industry .
• Strong knowledge of cGMP , FDA regulations , and validation protocols .
• Ability to work cross-functionally with engineering and operations teams.