What are the responsibilities and job description for the Quality Validation Engineer position at Intellectt Inc?
*Quality Validation Engineer**
Company: Intellectt Inc.
Danvers, MA*
Client- J&J
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 escalate 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
Pay Scale: $40 to $45 per hour on W2
Benefits
No Benefits
Salary : $40 - $45