Job Title: Quality Validation EngineerCompany: Novozen Health Care LLC.,Location: Danvers, MAJob Responsibilities: Seeking an experienced Quality Validation Engineer to support a large-scale equipment transfer and Business Continuity Planning (BCP) initiative within a medical device manufacturing environment in Danvers, MA. This individual will be responsible for owning validation activities associated with moving manufacturing equipment between production areas and sites, including bringing transferred equipment back into a qualified and operational state.
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.
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.
Required Qualifications: 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.
Pay Scale:
Anticipated hourly pay range: specific range such as ($44/Hr to $49/Hr).
Benefits:
Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements.
Health Insurance:
Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits:
A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO):
No PTO other than that required by applicable state and local laws.