Job Description

Job Title: Validation Engineer
Location: Boston, MA
Pay: $45/hr on W2
Work Environment: onsite

Job Summary:
Seeking Validation Engineers to support a large-scale QMS remediation and validation program for a regulated medical device manufacturer. These are hands-on, execution-focused roles involving validation remediation, documentation, compliance gap closure, and audit readiness.

Openings:

Facilities Validation Engineer: Facilities, utilities, equipment, environmental, and infrastructure qualification/validation.

• Process Validation Engineer: Manufacturing process validation, process qualification, and production-related validation.

Key Responsibilities:

• Execute IQ/OQ/PQ and process validation activities.
• Author, review, and execute validation protocols, reports, risk assessments, and documentation.
• Identify and remediate validation/compliance gaps.
• Review and update legacy validation documentation.
• Support deviations, investigations, CAPA, and remediation activities.
• Work with Quality, Manufacturing, Operations, and Engineering teams.
• Support FDA audit/inspection readiness and sustainable compliance improvements.

Required Qualifications:

• 3 5 years of Validation, Manufacturing Engineering, Quality Engineering, Process Engineering, or related experience.
• Experience in an FDA-regulated industry.
• Hands-on knowledge of IQ/OQ/PQ and validation lifecycle.
• Experience authoring/reviewing/executing validation protocols and reports.
• Strong technical writing and documentation skills .

Preferred:

• Medical device manufacturing experience.
• 21 CFR Part 820 / ISO 13485 experience.
• Validation remediation, FDA inspection, audit readiness, or warning letter response experience.
• Facilities, utilities, equipment, or process validation experience.
• Risk-based validation, CSV/CSA, 21 CFR Part 11.
• Experience with electronic/electromechanical medical devices.

Nice to Have One Resource:

• Experience with soldering, PCB/electronic assembly, or soldering process validation in medical device manufacturing.

Contact to Apply:

Name: Soundarya Kondra

Email: soundarya.kondra@intellectt.com

Phone: 732 204 6899

INTELLECTT INC

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.

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