Validation Engineer – Process & Facilities

Job Summary:
Support a medical device QMS remediation program under FDA oversight. Execute validation activities, close compliance gaps, update legacy documentation, and support inspection readiness.

Key Responsibilities:

• Author and execute IQ/OQ/PQ protocols, risk assessments, and validation reports.
• Support manufacturing process validation or facility, utility, and equipment qualification.
• Remediate validation documentation and resolve deviations, investigations, and CAPA.
• Collaborate with Quality, Manufacturing, and Engineering to complete remediation deliverables.

Requirements:

• 3 5 years of relevant experience in FDA-regulated manufacturing.
• Hands-on validation execution and strong technical writing skills.
• Ability to work independently and contribute with minimal ramp-up.
• Availability for the required onsite schedule.