Copy of Sr. Quality Engineer, Validations

Revance • Johnson City, TN

1d • Onsite

About The Position

Crown Laboratories is seeking an experienced Senior Quality Engineer, Validations, to lead and execute validation and qualification activities for complex manufacturing systems, equipment, utilities, and processes in a regulated cGMP environment. This role serves as a technical leader and Subject Matter Expert (SME), supporting lifecycle validation strategies, development-to-commercial transfers, and continuous compliance across the site.
The Senior Validation Engineer plays a key role in project planning, risk-based decision-making, regulatory compliance, and cross-functional collaboration, while mentoring junior engineers and contributing to site-wide validation standards and best practices.

Requirements

• Bachelor’s degree & 7+ years’ directly related experience.

Nice To Haves

• 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.

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.

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!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level