Quality Validation Engineer

Job Title: Quality Validation Engineer

Company: Novozen Health Care

Location: Danvers, MA (Onsite)

Employment Type: Contract (Approximately 12 months, with potential for extension)

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.