| Location | Danvers, MA |
| Salary | $45–$49 |
Company: Novozen Health Care
Location: Danvers, MA (Onsite)
Employment Type: Contract (Approximately 12 months, with potential for extension)
Job ResponsibilitiesLead 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.
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.
Anticipated hourly pay range: $45 $49 per hour on W-2, depending on experience and qualifications.
BenefitsEmployees 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.