Quality Validation Engineer

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

Duration: 12 months with possible extension

Employment Type: Contract - Onsite

Summary

The Validation Engineer will lead validation activities from planning through execution and closeout, including IQ/OQ/PQ, process validation, equipment qualification, Gauge R&R, and associated documentation. The equipment being transferred will vary significantly and may include manufacturing machinery, benches/workstations, gauges, laser equipment, and other production assets.

This person will work cross-functionally with engineering, manufacturing, quality, and other project stakeholders to coordinate validation activities around equipment moves and project timelines. The ideal candidate will be experienced, hands‑on, and highly self‑sufficient, with the ability to independently drive validation work forward and elevate issues when necessary without requiring significant day‑to‑day oversight.

Must Haves

• 5+ years of Quality Engineering / Validation Engineering experience, preferably within medical device, pharmaceutical, or another regulated manufacturing environment
• Strong hands‑on experience with equipment validation and qualification
• Strong experience developing and executing IQ/OQ/PQ protocols
• Experience with process validation
• Experience with Gauge R&R / measurement system analysis
• Experience creating, executing, and closing out validation protocols and supporting documentation
• Ability to independently own validation activities from planning through execution and closeout
• Experience working with a variety of manufacturing and production equipment
• Strong troubleshooting and problem‑solving capabilities
• Ability to work cross‑functionally with Quality, Manufacturing, and Engineering teams
• Highly self‑sufficient and able to manage deliverables with limited oversight
• Ability to work onsite in the Danvers, MA area to support equipment transfers and validation activities

Plusses

• Medical device manufacturing experience
• Previous experience within J&J / Abiomed or a similarly regulated medical device environment
• Experience supporting equipment relocation, manufacturing transfers, site transfers, or production line transfers
• Experience supporting Business Continuity Planning (BCP) initiatives
• Experience validating a broad range of equipment, including manufacturing machinery, gauges, laser equipment, benches/workstations, and other production assets
• Experience working in an environment operating under heightened Quality/FDA remediation or inspection‑readiness activities