Senior Validation Engineer - Equipment & Process

United Pharma Technologies Inc; New York (NY); On-site; USD 85,000 - 110,000; Full time

Job summary

A medical technology company is seeking a Senior Validation Engineer to lead validation activities in New York. You will oversee equipment qualification and process validation, ensuring compliance with FDA and ISO standards. The ideal candidate has over 7 years of experience in medical device manufacturing, a degree in Engineering, and strong skills in technical writing and communication. This role offers the opportunity to drive validation projects and ensure regulatory compliance.

Qualifications

• 7+ years of validation experience in medical device manufacturing.
• Knowledge of FDA QSR, ISO 13485, and GxP requirements.

Responsibilities

• Lead equipment qualification activities (IQ, OQ, TMV, PQ).
• Oversee process validation for FDA and ISO compliance.
• Author and review validation documentation including protocols.
• Support new equipment introductions and change control activities.
• Ensure compliance with FDA 21 CFR Part 820 and ISO 13485.

Skills

Strong hands-on experience with IQ/OQ/PQ

Technical writing

Communication skills

Education

Bachelor’s degree in Engineering or related field

Tools

eQMS systems (TrackWise, MasterControl, or similar)

Job description

A medical technology company is seeking a Senior Validation Engineer to lead validation activities in New York. You will oversee equipment qualification and process validation, ensuring compliance with FDA and ISO standards. The ideal candidate has over 7 years of experience in medical device manufacturing, a degree in Engineering, and strong skills in technical writing and communication. This role offers the opportunity to drive validation projects and ensure regulatory compliance.