Senior Process Engineer / CQV Validation Engineer

Job Title: Senior Process Engineer / CQV Validation Engineer
Company: Intellectt Inc
Location: Hialeah, FL
Pay: $52/hr
Work Environment: 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.

Name: Soundarya Kondra
Email:

soundarya.kondra@intellectt.com

Benefits:
Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms 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.

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