Senior CQV Engineer
Company: Johnson & Johnson
Location: Athens
Posted on: July 4, 2025
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Job Description:
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 / 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.
Keywords: Johnson & Johnson, Warner Robins , Senior CQV Engineer, Healthcare , Athens, Georgia
