Senior Process Engineer / CQV Validation Engineer

Role: Senior Process Engineer / CQV Validation Engineer
Location: Hialeah, FL
Rate: $45/hr - $50/hr
Duration: 12 Months
Schedule: 40 hrs/week
Work Model: Primarily Onsite

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.

Note: Primarily onsite in Hialeah, FL, with limited remote flexibility (1 2 days/week) based on management approval.

Contact to Apply:
Name: Uzma Kousar Mohammed
Email:

uzma.kousar@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.