Validation Engineer

Job Title: Validation Engineer Process & Facilities
Location: Boston
Duration: 14 months, with potential extension
Pay Rate: $40-$50/hr
Experience: 3 5 years

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.

Preferred
Medical device experience; knowledge of 21 CFR Part 820 and ISO 13485; FDA inspection, audit readiness, or QMS remediation experience. CSV/CSA and 21 CFR Part 11 exposure are a plus.

Contact to Apply:
Name: Pavani samboju
Email:
Phone732 993 4972
INTELLECTT INC