Senior Process Engineer / CQV Validation Engineer

Hello,

I hope you're doing well.

My name is Mahalakshmi, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity Senior Process Engineer / CQV Validation Engineer based Hialeah, FL (On-Site), at 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

mahalakshmi.n@intellectt.com

Job Summary

Seeking a Senior Process Engineer / CQV Validation Engineer with 5+ years of experience in pharmaceutical, medical device, or other FDA-regulated manufacturing environments.

Key Responsibilities

• Develop and execute IQ/OQ/PQ protocols and validation activities.
• Support process characterization, process validation, and equipment qualification.
• Prepare technical documentation and validation reports.
• Manage change controls, deviations, CAPAs, and risk assessments.
• Troubleshoot process and equipment issues and drive corrective actions.
• Collaborate with Engineering, Manufacturing, Quality, and other cross-functional teams.
• Ensure compliance with GMP and FDA-regulated requirements.

Requirements

• 5+ years of Process Engineering, Validation, CQV, or Manufacturing Engineering experience.
• Pharmaceutical, Medical Device, IVD, Diagnostics, Biotechnology, or similar regulated industry experience.
• Strong knowledge of GMP and validation documentation.
• Experience with IQ/OQ/PQ and process validation.
• Strong technical writing, analytical, and problem-solving skills.
• Ability to work independently and drive project deliverables.
• South Florida/local candidates preferred.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws
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,
Mahalakshmi
Junior Recruiter
Intellectt Inc

mahalakshmi.n@intellectt.com