Senior Commissioning, Qualification & Validation (CQV) Engineer
Senior Commissioning, Qualification & Validation (CQV) Engineer
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Job Description
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Supply Chain EngineeringJob Sub Function:
Process EngineeringJob Category:
Scientific/TechnologyAll Job Posting Locations:
Athens Georgia United States of AmericaJob 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 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 Bachelors / University or equivalent degree is required; an Engineering degree is strong desired 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 understanding and expertise in developing 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 () or contact AskGS to be directed to your accommodation resource.
Required Experience:
Senior IC
Employment Type
Full-Time
