Revance · 2 hours ago
Copy of Sr. Quality Engineer, Validations
Johnson City, TN
Full-time
Onsite
Senior Level
7+ years expCrown Laboratories is seeking an experienced Senior Quality Engineer, Validations, to lead and execute validation and qualification activities for complex manufacturing systems in a regulated cGMP environment. This role involves project planning, risk-based decision-making, and cross-functional collaboration while mentoring junior engineers and contributing to validation standards.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Lead validation lifecycle activities, including process validation, equipment qualification, utilities qualification, and engineering studies, ensuring alignment with regulatory and business requirements
Author, review, approve, and execute Installation, Operation, and Performance Qualifications or combined qualification protocols for complex systems and equipment trains, and using a risk-based approach
Serve as a Validation SME for assigned equipment, systems, and manufacturing processes, providing technical guidance and problem-solving support to Engineering, Manufacturing, Automation, and Quality teams
Drive Validation/Verification Process (VVP) activities to ensure on-time project execution for new product introductions, technology transfers, and commercial readiness
Develop and maintain validation strategies aligned with the site Master Validation Plan (MVP), ASTM E2500, and lifecycle validation principles
Lead and review Engineering Studies (ES), process characterization activities, and data analysis to support validation decisions and continuous improvement
Provide oversight and technical input for Master Batch Records, mistake-proofing efforts, and identification of critical process parameters and controls
Lead and support Change Control activities, including impact assessments, action plans, and validation execution to maintain the validated state
Mentor and provide technical oversight to Validation Engineer I and II personnel, supporting development of validation competencies and documentation quality
Participate in audits and inspections, supporting regulatory responses related to validation and qualification activities
Collaborate cross-functionally to support business objectives, quality initiatives, and compliance excellence
Qualification
Required
Bachelor's degree & 7+ years' directly related experience
Preferred
Bachelor's degree in Engineering, Life Sciences, or a related scientific discipline
7+ years of progressive experience in validation, quality engineering, or technical services within a cGMP-regulated environment
Strong working knowledge of 21 CFR Parts 210, 211, and 21 CFR Part 11
Demonstrated experience leading validation projects for manufacturing equipment, systems, and processes
Advanced proficiency in validation documentation practices, lifecycle validation, and risk assessment and risk management strategies
Strong leadership, communication, and cross-functional collaboration skills
Proven ability to manage multiple complex projects simultaneously and make risk-based decisions
Experience with process validation, continued process verification (CPV), and lifecycle management
Experience with automation systems, control systems, and equipment software/hardware/firmware
Prior experience supporting regulatory inspections (FDA, ISO, or other global agencies)
Experience mentoring junior engineers or leading validation teams
Flexible scheduling may be required to support project timelines, including off-shift or weekend activities
Infrequent travel may be required for Factory Acceptance Testing (FAT), vendor oversight, or training support
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
Steve Kreider
Executive Vice President, Chief Revenue Officer - Aesthetics and Therapeutics
Recent News
MarketScreener
2025-10-27
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