Equipment Engineer

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

Overview

We are seeking a Senior Validation Engineer to lead equipment and process validation activities in a regulated medical device manufacturing environment. This role is responsible for managing validation lifecycle activities, ensuring regulatory compliance, and independently driving validation projects from protocol development through execution and final reporting.

Responsibilities

• Lead equipment qualification activities (IQ, OQ, TMV, PQ) for manufacturing and test equipment.
• Oversee process validation to ensure compliance with FDA and ISO requirements.
• Author and review validation documentation including protocols, validation plans, FMEA, traceability matrices, deviations, and summary reports.
• Support new equipment introductions, transfers, re-qualifications, and change control activities.
• Ensure compliance with FDA 21 CFR Part 820, Part 11, ISO 13485, ISO 9001, cGMP, Annex 11, and GAMP.
• Partner cross-functionally with Manufacturing, Quality, Engineering, R&D, and Regulatory teams.
• Support audits as a validation SME.
• Assist with Computer System Validation (CSV) and software validation as needed.

Required Qualifications

• Bachelor’s degree in Engineering or related field.
• 7+ years of validation experience in medical device manufacturing.
• Strong hands-on experience with IQ/OQ/PQ and process validation.
• Knowledge of FDA QSR, ISO 13485, and GxP requirements.
• Experience with eQMS systems (TrackWise, MasterControl, or similar).
• Strong technical writing and communication skills.