Senior Quality Engineer. QMS

Johnson & Johnson Innovative Medicine•Athens, GA

22h•$81,000 - $131,100

About The Position

The Senior Quality Engineer provides technical quality leadership for computerized systems, equipment, and digital solutions in a regulated environment. The role develops and executes Computerized System Validation (CSV) strategies, applies risk-based approaches to qualification and validation, provides quality guidance for change management, and helps ensure data integrity throughout systems’ lifecycles. The position partners with Quality, Manufacturing, Engineering, IT, Automation, system owners, and business process owners to help ensure systems are fit for intended use, appropriately controlled, and maintained in a validated state. As a subject matter expert, the Senior Quality Engineer provides practical, risk-based guidance that balances compliance requirements, patient and product risk, and operational needs.

Requirements

Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related technical discipline.
Typically 5 or more 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 or 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.
Ability to critically review technical documentation and make independent, risk-based quality decisions.
Strong written and verbal communication skills, including the ability to explain technical and compliance concepts to technical and nontechnical stakeholders.

Nice To Haves

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 or 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 or SaaS applications, system integrations, or data migration projects.
Experience supporting regulatory inspections or internal or external audits.
Familiarity with deviation management, CAPA, periodic review, supplier assessment, and system lifecycle management.

Responsibilities

Support qualification and validation of equipment and systems, including computerized systems used in regulated business and manufacturing processes.
Apply risk-based approaches to determine the scope and rigor of qualification and validation activities.
Review and approve lifecycle documentation, including validation plans, user requirements, functional and configuration specifications, risk assessments, test protocols and scripts, traceability documentation, validation reports, and system retirement documentation.
Provide change-management direction and guidance on 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 investigations and resolution of validation discrepancies, test failures, and system-related quality issues.
Help ensure validated systems remain in a controlled state throughout their operational lifecycle.
Facilitate or participate in system, process, and functional risk assessments.
Use risk assessments to focus verification activities on functions with potential impact on product quality, patient safety, data integrity, or regulatory compliance.
Support qualification strategies for equipment, infrastructure, automation, and computerized systems, as applicable.
Provide technical quality support for data-integrity assessments and remediation activities.
Evaluate systems and processes for controls supporting ALCOA+ data-integrity principles, including user access, roles and permissions, audit trails, electronic records and signatures, data retention, backup and recovery, interfaces, and data lifecycle controls.
Participate in periodic computerized-system reviews and assessments to verify systems remain fit for intended use and appropriately controlled.
Support investigations involving suspected data-integrity issues and help determine corrective and preventive actions.
Partner with system owners and IT to identify sustainable controls for data governance and system administration.
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 documentation preparation and responses to questions about 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.
Collaborate cross-functionally to determine and address data and reporting needs.
Perform other Quality-related job duties as required.

Benefits

Participation in the Company’s consolidated retirement plan (pension), subject to plan terms.
Participation in the Company’s savings plan (401(k)), subject to plan terms.
Eligibility to participate in the Company’s long-term incentive program.
Vacation: 120 hours per calendar year, subject to applicable policies and date of hire.
Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington, subject to applicable policies and date of hire.
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, or foster care of a child.
Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.