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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 / University or equivalent degree in Engineering is required, preferably from an accredited college or university

EXPERIENCE AND SKILLS:

Required:

- Minimum of 2 years of relevant work experience

- Experience conducting commissioning, qualification, and/or validation

- Experience within one or more of the following industries: Biopharmaceutical, Pharmaceutical, and/or Medical Device

- Proven experience qualifying cleanroom areas and/or large-scale process equipment (e.g., vessels, centrifuges, filter presses, and/or CIP skids)

- Strong expertise in writing and executing validation protocols (IQ, OQ, PQ)

- Strong technical writing skills, including experience preparing final validation reports

- Working knowledge of GMP, FDA regulations, and industry best practices

- Familiarity with process automation, control systems (e.g., DeltaV, Rockwell, Siemens), and data integrity requirements

- Ability to work independently and collaborate with cross-functional teams

- Excellent problem-solving skills and attention to detail

Preferred:

- Experience with small molecule (chemical synthesis) pharma equipment validation

- Understanding of risk-based validation approaches (e.g., ASTM E2500, ISPE guidelines)

- Experience as SME for Health Authority Audits

- Knowledge of change control, deviation management, and/or CAPA processes within the Trackwise or COMET QEM systems

OTHER:

- May require up to 10% domestic travel

- Requires the ability, through our hybrid flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.