Sr. Quality Engineer, Validations

Job Summary:

The Sr. Quality Engineer, Validation provides technical and quality leadership in the planning, execution, and lifecycle management of validation programs primarily covering Facilities and Utilities and able to support site Quality improvement initiatives. They must be proficient with Equipment Qualifications, understand Computerized Systems Validation and be able to assess Process Validations in order to align tasks and risks used to support the Site Master Validation Plan (MVP). This role ensures that all validated and qualified systems supporting Pharmaceutical (Rx), OTC, and Cosmetic manufacturing operate in a state of control, and remain compliant with FDA 21 CFR Parts 210, 211, 820, and 11, EU Annex 15, ICH Q7-Q10, and GAMP 5 guidelines. The Sr. QE/Validation partners cross-functionally with Quality, Operations, Engineering, and Maintenance to manage validation and process qualification projects, strengthen process capability, enhance equipment reliability, and uphold Crown's Quality Systems through technical accuracy, risk-based validation, and data integrity excellence.

Reporting to: Sr. Quality Assurance Manager, Technical Services (Validation)
Location: Johnson City, TN - onsite

Responsibilities/Essential Duties:

Validation and Qualification Program Management:

• Support, write and/or execute Validation Master Plans (VMPs), User Requirement Specifications (URS), Design/Configuration Specifications (DS/CS), Installation/Operational/Performance Qualifications (IQ/OQ/PQ), and Validation Summary Reports (VSRs) in support of the Master Validation Plan.
• Lead Process Validation (PV) lifecycle activities, including Process Design, Process Qualification, and Continued Process Verification ensuring alignment with ICH Q8/Q9/Q10 and FDA PV Guidance (2011).
• Author and review Process Validation Protocols, define Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), and apply statistical analysis to confirm process capability (Cpk/Ppk).
• Develop and maintain Requirements Traceability Matrices (RTMs) linking user requirements, risk assessments, and qualification test outcomes.
• Execute testing, verifications and assessments of risk for primarily Facilities and Utilities, including HVAC, USP Purified Water Systems, and Compressed Air. Coordinate area-related Equipment Qualification and Engineering Studies. Assist with establishing facility environmental controls such as Temperature Monitoring using Vaisala/ViewLinc. Possess skills for risk assessment evaluations, for example, area facility equipment including autoclaves, incubators, bulk processors, and packaging filling equipment. Ability to serve as the site's Facility and Utility Qualification expert, the Subject Matter Expert (SME) at a Senior level.
• Support Factory Acceptance Testing (FAT), Site Acceptant Testing (SAT), commissioning, and qualification transitioning for systems.
• Maintain validation deliverables in compliance with GDP and ALCOA+ data integrity principles.

Process Validation and Lifecycle Management:

• Lead and execute Process Validation following FDA and ICH guidance, including process characterization, strategy development, and ongoing verifications.
• Partner with Manufacturing and QA to ensure validated processes consistently produce material meeting predetermined specifications and quality attributes.
• Perform data trending, statistical analysis, and process capability studies to monitor validated processes and identify opportunities for improvement.
• Support Continued Process Verification programs and control systems monitoring by maintaining control charts, analyzing deviations and trends, and providing periodic validation and qualification reviews.
• Ensure validation documentation completed is current, traceable, and readily available for inspection.

Change Control and Procedural Controls:

• Author and support Change Controls, Engineering Studies, CAPAs, and Deviation Investigations associated with validation and process changes. Ability to access SOP instruction and controls.
• Identify and establish as needed any procedural and system controls to sustain validated and qualified states; document alarm limits and identify for assuring control over the process.
• Contribute to the development and maintenance of Validation SOPs, Work Instructions, and Templates to standardize validation activities.

Cross-Functional Collaboration and Project Leadership:

• Coordinate communications among Quality, Operations, Engineering, and Maintenance to ensure timely execution of validation and process qualification projects.
• Provide technical validation guidance to project teams and ensure inspection readiness during internal, corporate, and regulatory audits.
• Lead validation-related meetings, track milestones, and communicate project progress to management and stakeholders.

Process Improvement and Technical Expertise:

• Apply risk-based engineering principles and GAMP 5 methodologies to enhance process and equipment performance, reduce variability, and improve throughput.
• Lead root-cause investigations (5-Why, Fishbone, DMAIC), determine root cause or causes and implement Corrective and Preventive Action Plans (CAPAs) that truly strengthen process controls.
• Leverage historical data and validation archives to support continuous improvement and future technology transfer projects.
• Develop SME knowledge in all things Validation including cleaning validation and analytical method development and qualification to future support continued site knowledge and program continuity.

Basic Qualifications:

• Bachelor's degree & 5+ years' directly related experience.

Preferred Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline.
• 5+ years' experience in Validation and Quality roles.
• Personnel and project supervisory experiences are preferred for the Senior Level role.
• Advanced degree and/or ASQ/ISPE certifications.
• Preferred 8 years' experience in Validation/Quality Roles with progressive experience in validation and/or process and/or Quality Engineer roles within a regulated cGMP environment.
• Proven experience writing and executing IQ/OQ/PQs, as well as writing Validation Plans, URS, RTM, and Summary Reports.
• Strong working knowledge of 21 CFR Parts 210, 211, 820, and 11, EU Annex 15, ICH Q8-Q10, and GAMP 5.
• Experience qualifying utilities, process equipment, and systems; familiarity with automation, PLC/HMI interfaces, and 21 CFR Part 11 data-integrity control.
• Expertise in authoring and executing validation protocols with scientific rationale, statistical justification, and clear acceptance criteria.
• Proficient in interpreting P&IDs, system flow diagrams, control logic, and engineering schematics.
• Skilled in using Microsoft Office suite and SharePoint. Advanced knowledge in QMS, LIMS, and automated Validation systems software.
• Experienced with firmware/hardware/software configuration management and system lifecycle documentation.
• Strong technical writing and analytical skills with ability to translate complex test data into concise regulatory documentation.
• Excellent written and verbal communication skills with diverse technical and operational audiences.
• Demonstrated ability to manage multiple concurrent validation and qualification projects.
• Strong analytical, organizational, and leadership capability, emphasizing accuracy, compliance, and cross-functional collaboration.
• Primarily office and controlled manufacturing floor environment; routine interaction with utility areas.
• Minimal lifting or physical exertion required.
• Occasional off-shift or weekend work during critical validation or qualification phases.
• Limited travel (<10%) for FATs, vendor audits, or specialized training.

Company Summary:

Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.

What Revance invests in you:

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.