New · posted Oct 27
Johnson & Johnson · Biotechnology
QA Validation Specialist II LVV
- Raritan, NJ
- On-site
- Full-time
- Associate & Specialist
The role
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 jnj.com
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Johnson & Johnson is currently recruiting for QA Validation Specialist II LVV! .This position will be located in Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.Janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.
Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.
In this role, you will be providing quality oversight for daily activities related to the production of analytical cell banks, cryopreservation of human apheresis and testing of viral vectors in a controlled cGMP environment. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.
Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!
What you need
Education
A minimum of a Bachelor’s Degree is required, with a focused degree in Engineering, Science or equivalent technical field preferred.
Required
Minimum 2 years of industry experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry.
Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidance
Ability to be organized and capable of working in a team environment with a positive demeanor.
A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
Ability to work independently on routine tasks.
Ability to maintain written records of work performed in paper-based and computerized quality systems.
Preferrednice to have
Experience with quality support in clinical or GMP manufacturing or support of operation clean-rooms is preferred.
Experience with the manufacture of cell and gene therapy products as well as knowledge of Good Tissue Practices is preferred.
What you'll do
Main Responsibilities will include, but are not limited to
Applies Quality Assurance knowledge of guidelines and surfaces issues that may impact organizational objectives.
Environmental Monitoring Data
Review and ensure compliance of viable and non‑viable particulate monitoring, airflow, differential pressure, humidity, and temperature data needed for cleanroom release.Verify Compliance with GMP and ISO Cleanroom Standards
Assess cleanroom performance against ISO 14644 and GMP Annex 1 requirements, including cleanliness levels "at rest" and "in operation when needed.Evaluate Contamination Control and HVAC Performance
Monitor and review contamination control measures, including HVAC performance, surface cleanliness, and particulate control, to ensure clean-rooms maintain required class standards when required.Document Validation Activities and Maintain Cleanroom Validation Records
Maintain detailed validation protocols, results, deviations, corrective actions, and environmental monitoring logs as required for regulatory compliance and audit readiness.Support Investigations
Oversee Equipment/Facility/Process Qualification (URS/Config Specs/QRA/IQ/ OQ/PQ/AVS/EMPQ/APS)
Perform or review equipment qualification—including installation, operational, and performance qualification—ensuring systems perform consistently for intended use.Oversee Computerized System Validation (CSV)
Must ensure that the selection, validation, maintenance and retirement of computerized systems that are handled in a consistent manner following a standardized process. Provide CSV support of Process of planning, Installation, Validation, Upgrades/modifications, operation, maintenance, and retirement of the computerized system used as part of the GxP regulated using the manufacturing area from Concept Phase through to the Retirement Phase. Be familiarized with AIQ and RBA deliverables, such as GAMP categories, and AIQ, Annex 11, Part 11, Data Integrity, EHS&S, System Impact assessments and Traceability/Test Matrix.Review Calibration and Preventive Maintenance Status and Confirm GMP Compliance of Equipment Documentation
Verify that all equipment has current calibration, maintenance, and is functioning within validated parameters prior to approving release.Address Equipment Validation Deviations
Investigate validation failures, equipment performance issues, or deviations discovered during IQ/OQ/PQ/CSV/AVS/EMPQ/APS testing and ensure resolution before releasing equipment for use.Approve Equipment for Use in Production or Testing
Following successful validation and documentation review, the QA validation specialist authorizes equipment as fit for use, ensuring it meets defined acceptance criteria.Support Continuous Improvement of Equipment Validation Processes
Other tasks, an needed
Pay and benefits
$65,000 – $117,000 a year
Employer providedOther
Requires ability and flexibility to work 8-hour shifts 1st shift Monday - Friday, and provide occasional off shift or weekend support, as needed.
This position is located primarily in Raritan, NJ, and may require up to 5% local travel.
The anticipated base pay range for this position is $65,000.00 - $
117,000.00
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
The anticipated base pay range for this position is
$65,000.00 - $104,650.00
Medical, dental, vision insurance
Life and disability insurance
Pension and 401(k) savings plan
Vacation, sick and holiday pay
Annual performance bonus
Parental and other leave
Where you'll work
Raritan, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Raritan, NJWorking conditions
Job Function
Quality
Job Sub Function
Quality Assurance
Job Category
Professional
All Job Posting Locations
Raritan, New Jersey, United States of America
Equal opportunity, accessibility and legal noticesJohnson & Johnson's statements, word for word
Additional Description for Pay Transparency
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Job intelligence
The context around this role
Live data · October 28, 2026
Salary intelligence
How the pay compares
This role's midpoint is 13% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US22 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $65,000 | — | $117,000 |
| All US (middle half) | $77,000 | $80,500 | $91,750 |
This role: Johnson & Johnson's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 28, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 123 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Johnson & Johnson's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance8
- Validation and qualification8
- Documentation and SOPs6
- Collaboration and leadership5
- Lab testing and methods4
- Investigations and CAPA4
- Quality systems and risk2
- Data and digital systems2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Johnson & Johnson on Regulatory Jobs
- 45
- Open roles
- 44
- Distinct roles
- 22
- Locations
By discipline
- Quality31 69%
- Regulatory11 24%
- Compliance & Safety3 7%
By level
- Associate & Specialist16 36%
- Senior & Principal15 33%
- Manager11 24%
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QA Validation Specialist II LVV at Johnson & Johnson
Applications close November 2. $65K–$117K a year, employer provided.