Senior Validation Engineer - Medical Devices (IQ/OQ/PQ)

Intellectt Inc; Danvers (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Intellectt Inc in Massachusetts seeks a Validation Engineer for a 12-month contract onsite role. You will lead validation activities from planning through execution and closeout, including IQ/OQ/PQ, process validation, equipment qualification, Gauge R&R, and associated documentation.

You will work cross-functionally with engineering, manufacturing, and quality teams to coordinate validation around equipment moves and timelines.

Qualifications

• 5+ years in Quality or Validation engineering in regulated manufacturing.
• Hands-on equipment validation and qualification experience.
• Experience developing IQ/OQ/PQ protocols and process validation.
• Familiar with Gauge R&R / measurement systems analysis.
• Ability to own validation activities from planning to closeout.
• Onsite work experience in a manufacturing environment.

Responsibilities

• Lead validation activities from planning through execution and closeout (IQ/OQ/PQ) with documentation.
• Coordinate validation around equipment moves and project timelines.
• Work cross-functionally with Quality, Manufacturing, and Engineering teams.
• Independently drive validation work with limited day-to-day oversight.

Skills

Quality/Validation engineering

Equipment validation

IQ/OQ/PQ protocols

Process validation

Gauge R&R / MSA

Validation protocols & documentation

Independent ownership

Cross-functional collaboration

Job description

Intellectt Inc in Massachusetts seeks a Validation Engineer for a 12-month contract onsite role. You will lead validation activities from planning through execution and closeout, including IQ/OQ/PQ, process validation, equipment qualification, Gauge R&R, and associated documentation.

You will work cross-functionally with engineering, manufacturing, and quality teams to coordinate validation around equipment moves and timelines.