Validation Engineer (Medical Device) - Intellectt INC

Job Title: Validation Engineer (Medical Device)
Location: Boston ,MA
Duration : 12+ Months

Job Description:
We are seeking a detail-oriented and experienced Validation Engineer to join our team. The ideal candidate will be responsible for ensuring equipment, systems, and processes meet regulatory standards and operate effectively. This role requires a deep understanding of validation protocols, strong problem-solving skills, and the ability to collaborate with cross-functional teams to meet compliance requirements in an FDA-regulated or ISO-certified environment.

Key Responsibilities:

• Develop, execute, and review validation protocols (IQ, OQ, PQ) for equipment, facilities, and processes
• Ensure compliance with FDA, ISO 13485, and GMP standards in validation activities
• Perform risk assessments and gap analysis on validation processes
• Support process improvement initiatives and continuous validation efforts
• Collaborate with quality, manufacturing, and engineering teams to troubleshoot validation issues
• Maintain validation documentation and records for audits and regulatory submissions
• Oversee equipment calibration and maintenance schedules

Required Skills:

• Strong understanding of validation protocols (IQ, OQ, PQ)
• Knowledge of FDA regulations, ISO standards, and GMP guidelines
• Proficient in technical writing and documentation
• Excellent problem-solving and analytical skills
• Ability to work cross-functionally in a regulated environment