Senior CQV Engineer

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Supply Chain Engineering

Job Sub Function:
Process Engineering

Job Category:
Scientific/Technology

All Job Posting Locations:
Athens, Georgia, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine.

We are searching for the best talent for Senior CQV (Commissioning, Qualification, and Validation) Engineer! This hybrid position will be located in Athens, Georgia!

Are you interested in joining a team that is helping improve patient care and drive innovation? At Johnson & Johnson, we blend heart, science, and ingenuity to profoundly change the trajectory of health for humanity.

Apply today for this exciting opening to support us at our pharmaceutical plant!

The Senior CQV Engineer is responsible for supporting the qualification of cleanroom facilities and large process equipment at pharmaceutical manufacturing sites in Athens, GA.

They will also be responsible for hands-on writing and executing of qualification protocols (IQ, OQ, PQ) and preparing final validation reports.

Key Responsibilities:

- Perform CQV activities for cleanroom areas and large process equipment, including but not limited to: Vessels (Bioreactors, Fermenters, Mixing Tanks); Centrifuges; Pharma Dryers; and/or CIP (Clean-in-Place) Skids.

- Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.

- Generate and maintain validation documentation, including final reports ensuring compliance with GMP, FDA, and industry standards.

- Work closely with engineering, quality, and operations teams to troubleshoot validation challenges and implement corrective actions.

- Support regulatory audits and inspections by providing validation documentation and justifications.

- Ensure compliance with cGMP, 21 CFR Part 11, ISPE Baseline Guides, and ASTM E2500 methodologies.

- Assist in risk assessments, change control evaluations, and impact assessments for equipment modifications.

QUALIFICATIONS:

EDUCATION:

- Minimum of a Bachelor's ...