Quality Validation Engineer

Job Title: Quality Validation Engineer

Company: Novozen Health Care

Location: Danvers, MA

Employment Type: Contract 12 months,

Job Responsibilities

• Lead equipment validation and qualification activities supporting equipment transfers and Business Continuity Planning (BCP) initiatives within a regulated medical device manufacturing environment.
• Develop, execute, and close out validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Perform process validation, equipment qualification, and Gauge R&R / measurement system analysis.
• Support the relocation and requalification of manufacturing equipment, including machinery, gauges, laser equipment, benches, workstations, and other production assets.
• Prepare and maintain validation documentation and ensure compliance with applicable quality and regulatory requirements.
• Collaborate with Quality, Manufacturing, and Engineering teams to coordinate validation activities and meet project timelines.
• Troubleshoot equipment and validation issues, identify potential risks, and implement appropriate corrective actions.
• Independently manage validation activities from planning through execution and final closeout, escalating issues when necessary.
• Support equipment transfers, manufacturing transitions, and production continuity initiatives.

Required Qualifications

• Minimum of 5 years of Quality Engineering or Validation Engineering experience, preferably in medical device, pharmaceutical, or other regulated manufacturing environments.
• Strong hands-on experience in equipment validation and qualification.
• Proven experience developing and executing IQ/OQ/PQ protocols.
• Experience with process validation and Gauge R&R / measurement system analysis.
• Ability to create, execute, review, and close out validation protocols and supporting documentation.
• Experience working with a variety of manufacturing and production equipment.
• Strong troubleshooting, analytical, and problem-solving skills.
• Ability to work cross-functionally with Quality, Manufacturing, and Engineering teams.
• Demonstrated ability to independently manage validation deliverables with minimal supervision.
• Ability to work onsite in Danvers, MA, to support equipment transfers and validation activities.

Preferred Qualifications:

• Previous experience in medical device manufacturing, preferably with J&J, Abiomed, or a similar regulated medical device organization.
• Experience supporting equipment relocation, manufacturing transfers, site transfers, or production line transfers.
• Previous involvement in Business Continuity Planning (BCP) initiatives.
• Experience validating diverse production assets, including manufacturing machinery, gauges, laser equipment, benches, and workstations.
• Experience working in environments involving FDA remediation, heightened quality oversight, or inspection-readiness activities.

Pay Scale

Anticipated hourly pay range $45–$49 per hour on W-2, depending on experience and qualifications.

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.