New · posted Oct 22
Johnson & Johnson · Pharmaceuticals
Senior Quality Engineer, QMS
- Athens, GA
- On-site
- Full-time
- Senior & Principal
Closes Nov 4, 2026 · 13 days left
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.
The Senior Quality Engineer provides technical quality leadership for computerized systems, equipment, and digital solutions used within a regulated environment. This role is responsible for developing and executing Computerized System Validation (CSV) strategies, applying risk-based approaches to qualification and validation, providing quality guidance with change management, and ensuring systems and processes maintain appropriate data integrity throughout their lifecycle.
The Senior Quality Systems Engineer partners with Quality, Manufacturing, Engineering, IT, Automation, system owners, and business process owners to ensure that systems are fit for intended use, appropriately controlled, and maintained in a validated state. The position serves as a subject matter expert and provides practical, risk-based guidance that balances compliance requirements, patient/product risk, and operational needs
What you need
Required Qualifications
- Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical discipline.
- Typically 5+ years of relevant experience in Quality, Validation, Engineering, Automation, IT Quality, or a related function within a regulated environment.
- Demonstrated experience with computerized system validation and/or equipment/system qualification.
- Experience performing or reviewing risk assessments and translating risk into appropriate validation or qualification activities.
- Working knowledge of change-control processes and validated lifecycles.
- Strong understanding of data-integrity principles and controls associated with electronic records, required.
- Demonstrated ability to review technical documentation critically and make independent, risk-based quality decisions.
- Strong written and verbal communication skills, including the ability to explain technical and compliance concepts to both technical and nontechnical stakeholders.
- Collaborate cross-functionally to determine and address data and reporting needs.
- Performs other Quality-related job duties as required.
Preferred Qualificationsnice to have
- Experience in pharmaceutical, biopharmaceutical, medical device, or other regulated manufacturing environments.Knowledge of GxP, 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and quality risk-management concepts.Experience with risk-based computerized system assurance/validation approaches.Experience reviewing or validating configurable or commercial systems such as LIMS, MES, ERP, EDMS, LMS, laboratory systems, manufacturing systems, or quality management systems.Experience with automation, infrastructure, cloud-based/SaaS applications, system integrations, or data migration projects.Experience supporting regulatory inspections or internal/external audits.Familiarity with deviation management, CAPA, periodic review, supplier assessment, and system lifecycle management.
Key Competencies
- Risk-Based Decision Making: Uses documented risk and scientific/technical rationale to determine the appropriate level of control.
- Technical Quality Leadership: Provides credible guidance while appropriately challenging both compliance gaps and unnecessary complexity
- .Problem Solving: Identifies root causes and develops sustainable solutions rather than relying solely on additional documentation or testing.
- Cross-Functional Collaboration: Works effectively across Quality, IT, Engineering, Manufacturing, Automation, and business functions.
- Data Integrity Mindset: Understands how system design, configuration, security, procedures, and human behavior affect the reliability of regulated data.
- Lifecycle Thinking: Considers validation and compliance from initial requirements and implementation through operation, change, periodic review, and retirement.
- Continuous Improvement: Looks for opportunities to simplify processes, leverage existing objective evidence, and focus resources on activities that meaningfully reduce risk.
Preferred Skillsnice to have
Analytical Reasoning, Business Alignment, Business Behavior, Coaching, Collaboration, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Systems Analysis, Training People
What you'll do
- Support qualification and validation activities for equipment, systems, including computerized systems used in regulated business and manufacturing processes.
- Apply a risk-based approach to determine the appropriate scope and rigor of qualification and validation activities.
- Review and approve lifecycle documentation such as validation plans, user requirements, functional and configuration specifications, risk assessments, test protocols/scripts, traceability documentation, validation reports, and system retirement documentation.
- Provide change management direction and guidance on appropriate validation strategies based on intended use, system complexity, regulatory impact, and risk.
- Provide quality oversight for implementation, upgrades, configuration changes, integrations, migrations and retirement of computerized systems.
- Support investigation and resolution of validation discrepancies, test failures, and system-related quality issues.
- Ensure validated systems remain in a controlled state throughout their operational lifecycle.
- Facilitate and/or participate in system, process, and functional risk assessments.
- Use risk assessments to focus verification activities on functions that have the greatest potential impact on product quality, patient safety, data integrity, or regulatory compliance.
- Support qualification strategies for equipment, infrastructure, automation, and computerized systems, as applicable.
- Serve as a technical quality resource for data integrity assessments and remediation activities.
- Evaluate systems and processes for controls supporting ALCOA+ data integrity principles.
- Assess areas such as user access, roles and permissions, audit trails, electronic records, electronic signatures, data retention, backup/recovery, interfaces, and data lifecycle controls.
- Participate in periodic reviews and assessments of computerized systems to verify that systems remain fit for intended use and appropriately controlled.
- Support investigations involving suspected data-integrity issues and assist in determining appropriate corrective and preventive actions.
- Partner with system owners and IT to identify sustainable controls for data governance and system administration.
QS & Tech Leadership
- Provide subject matter expertise and guidance on validation, qualification, change control, and data integrity requirements.
- Interpret regulatory and industry expectations and translate them into practical, risk-based quality solutions.
- Coach engineers, system owners, validation personnel, and cross-functional partners on compliant validation and quality-system practices.
- Support inspection and audit readiness, including preparation of documentation and responses to questions related to computerized systems and validation.
- Participate in internal audits, regulatory inspections, and remediation activities as needed.
- Identify recurring compliance or process issues and recommend systemic improvements.
- Lead or contribute to continuous-improvement initiatives that simplify validation processes while maintaining effective quality controls.
Pay and benefits
$79,000 – $127,650 a year
Employer providedThe anticipated base pay range for this position is
$79,000.00 - $127,650.00
401(k) savings plan
Pension plan
Vacation (120 hours per year)
13 paid holidays
Parental leave
Long-term incentive program
Where you'll work
Athens, GAOn-siteOpen in Maps (opens in a new tab)
More jobs in Athens, GAWorking conditions
Job Function
Quality
Job Sub Function
Quality Systems
Job Category
Professional
All Job Posting Locations
Athens, Georgia, 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)).
This position is eligible to participate in the Company’s long-term incentive program.
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
Job intelligence
The context around this role
Live data · October 23, 2026
Salary intelligence
How the pay compares
This role's midpoint is 14% below the US median for Validation & CQV roles at this level.
This roleEmployer provided
Senior & Principal roles in the US51 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $79,000 | — | $127,650 |
| All US (middle half) | $104,250 | $119,500 | $129,500 |
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 23, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 120 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 48 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification19
- Data and digital systems17
- GMP and compliance11
- Documentation and SOPs9
- Quality systems and risk9
- Collaboration and leadership9
- Lab testing and methods5
- Investigations and CAPA4
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
- 39
- Open roles
- 38
- Distinct roles
- 19
- Locations
By discipline
- Quality24 62%
- Regulatory13 33%
- Compliance & Safety2 5%
By level
- Senior & Principal13 33%
- Associate & Specialist12 31%
- Manager10 26%
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Senior Quality Engineer, QMS at Johnson & Johnson
Applications close November 4. $79K–$128K a year, employer provided.