Validation Engineer

Job Title: Validation Engineer Process & Facilities
Location: Boston, MA
Pay: $48/hr
Work Environment:3 weeks onsite / 1 week remote per month
Industry: Medical Devices Interventional Cardiology

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.Additional Plus for One Opening: Soldering, PCB/electronic assembly, or related process validation experience.

Contact to Apply:
Name: Soundarya Kondra
Email:

soundarya.kondra@intellectt.com

Benefits:
Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.