Validation Engineer - Process & Facilities

Hello,

I hope you're doing well.

My name is Rudra , and I'm reaching out from Intellectt Inc . regarding an exciting contract opportunity for Validation Engineer Process & Facilities based in Boston, MA with one of our prestigious clients. I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at View email address on us.fitly.work

Job Title: Validation Engineer Process & Facilities
Location: Boston, MA
Work Arrangement: 3 weeks onsite / 1 week remote per month
Experience Level: 3 5 Years
Pay rate: $40-$50/hr on W2

Skills: IQ/OQ/PQ Validation | Process Validation | Facilities/Equipment Qualification | Risk Assessments | Validation Documentation | Deviations & Investigations | CAPA | FDA-Regulated Manufacturing | Medical Devices | 21 CFR Part 820 | ISO 13485 | QMS Remediation | FDA Inspection Readiness | Technical Writing | CSV/CSA | 21 CFR Part 11

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.

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.

Thanks & Regards,




Kunnath Rudra Prasad
Technical Recruiter
Intellectt Inc



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