Revance · 6 days ago
Sr. Quality Engineer, Validations
Johnson City, TN
Full-time
Onsite
Senior Level
5+ years expRevance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. The Sr. Quality Engineer, Validations provides technical and quality leadership in managing validation programs for Facilities, Utilities, Equipment, and Process, ensuring compliance with regulatory standards and enhancing process capability.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Develop, execute, and approve 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 (PPQ), and Continued Process Verification (CPV), 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 for Facilities, Utilities, Equipment, and Process, including HVAC, WFI/RO water systems, compressed air, autoclaves, incubators, filling lines, and compounding equipment
Support Factory Acceptance Testing (FAT), Site Acceptant Testing (SAT), commissioning, and qualification transition for new or modified systems
Maintain validation deliverables in compliance with cGDP and ALCOA+ data integrity principles
Lead and execute Stage 1-3 Process Validation following FDA and ICH guidance, including process characterization, PPQ strategy development, and ongoing verification
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 (CPV) by maintaining control charts, analyzing deviations and trends, and providing periodic validation reviews
Ensure all process validation documentation is current, traceable, and readily available for inspection
Author and support Change Controls, Engineering Studies, CAPAs, and Deviation Investigations associated with validation and process changes
Establish procedural and system controls to sustain validated and qualified states; document alarm limits and critical control points
Contribute to the development and maintenance of Validation SOPs, Work Instructions, and Templates to standardize validation activities
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
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) and implement CAPAs that strengthen process controls
Leverage historical data and validation archives to support continuous improvement and future technology transfer projects
Develop SME knowledge in process validation, cleaning validation, and analytical method qualification domains to support knowledge continuity
Qualification
Required
Bachelor's degree & 5+ years' directly related experience
Develop, execute, and approve 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 (PPQ), and Continued Process Verification (CPV), 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 for Facilities, Utilities, Equipment, and Process, including HVAC, WFI/RO water systems, compressed air, autoclaves, incubators, filling lines, and compounding equipment
Support Factory Acceptance Testing (FAT), Site Acceptant Testing (SAT), commissioning, and qualification transition for new or modified systems
Maintain validation deliverables in compliance with cGDP and ALCOA+ data integrity principles
Lead and execute Stage 1-3 Process Validation following FDA and ICH guidance, including process characterization, PPQ strategy development, and ongoing verification
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 (CPV) by maintaining control charts, analyzing deviations and trends, and providing periodic validation reviews
Ensure all process validation documentation is current, traceable, and readily available for inspection
Author and support Change Controls, Engineering Studies, CAPAs, and Deviation Investigations associated with validation and process changes
Establish procedural and system controls to sustain validated and qualified states; document alarm limits and critical control points
Contribute to the development and maintenance of Validation SOPs, Work Instructions, and Templates to standardize validation activities
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
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) and implement CAPAs that strengthen process controls
Leverage historical data and validation archives to support continuous improvement and future technology transfer projects
Develop SME knowledge in process validation, cleaning validation, and analytical method qualification domains to support knowledge continuity
Preferred
Bachelor's degree in Engineering, Life Sciences, or related technical discipline
Advanced degree or ASQ/ISPE certification
Minimum 5-8 years' progressive experience in validation and/or process engineering within a regulated cGMP environment
Proven experience executing IQ/OQ/PQ, Process Validation (PPQ/CPV), and 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 analytical systems; familiarity with automation, PLC/HMI interfaces, and Part 11 data-integrity controls
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 Microsoft Office, Master Control, and electronic validation/quality systems
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 process qualification projects
Strong analytical, organizational, and leadership capability, emphasizing accuracy, compliance, and cross-functional collaboration
Benefits
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!
Company
Revance
We believe that science-powered innovation creates possibilities.
1001-5000 employees
H1B Sponsorship
Revance has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (16)
2023 (8)
2022 (10)
2021 (16)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.68BKey Investors
Athyrium Capital Management LPEssex Woodlands Healthcare PartnersMedicis Pharmaceutical
2024-08-12Acquired
2024-03-04Post Ipo Equity· $100M
2022-09-12Post Ipo Equity· $200M
Leadership Team
Nadeem Moiz
Chief Executive Officer
Jeffery Bedard
Founder/Executive Chairman Board of Directors
Recent News
MarketScreener
2025-10-27
Company data provided by crunchbase