Quality Engineer I

Job Summary:

The Quality Engineer I will create and execute facility, utility and equipment qualification protocols for key projects that impact Crown's quality systems, and in support the site Master Validation Plan.

Reporting to: Sr. Manager, Quality Assurance
Location: Johnson City, TN - onsite
Schedule: Monday - Friday, 8:00am - 5:00pm

Responsibilities/Essential Duties:

• Support facility, utility, and equipment qualification and validation activities in compliance with cGMP requirements (21 CFR 210/211, Part 11 as applicable)
• Develop, execute, and summarize validation documentation including validation plans, protocols (IQ/OQ/PQ), and final reports
• Assist in the development and implementation of procedural and system controls to ensurerepeatability and documentation of critical parameters
• Support and/or initiate Change Controls, ensuring appropriate documentation, impactassessment, and compliance with quality system requirements
• Execute testing protocols and procedures to support equipment and system qualification andongoing control strategies
• Collaborate cross-functionally with Quality, Operations, Engineering, and Maintenance to ensure timely completion of validation and quality-related project deliverables
• Support deviation investigations, Nonconformance (NCM), and CAP A activities, including root cause analysis and effectiveness verification, as required
• Participate in risk assessments (e.g., FMEA, risk-based validation approaches) to supportcompliant and efficient validation strategies
• Identify and support process improvements and troubleshooting activities for equipment and systems, ensuring alignment with quality and compliance requirements
• Maintain accurate and complete documentation in accordance with cGDP and data integrity expectations

Basic Qualifications:

• Bachelor's degree in Scientific Discipline.

Preferred Qualifications:

• Bachelor's degree in Engineering, or Bachelor's degree with suitable work history.
• Ability to create and/or manage Validation Plans, User Requirement Specifications, applicable Configuration Specifications, Installation, Operation and Performance Qualifications, Requirements Trace Matrix, and Summary Reports as project support documents to assure on-time completion of projects and for demonstrating compliance requirements.
• Ability to create procedural controls to ensure continued system maintenance and compliance.
• Assist system owner with writing Change Control action items or other project documentation.
• Excels in compiling multiple forms of communications that describe the completed system.
• Ability to simplify and organize information to create test plans.
• Ability to create written test steps for positively and negativity testing the system utilizing as applicable user roles and then documenting in cGDP format for each tested scenario.
• Ability to summarize the collected testing data, including any deviation for required corrective/preventive actions, and for Quality Assurance review and approval.
• Ability to problem-solve and fully participate in diverse cross-functional teams to achieve business objectives.
• Excellent written and verbal communications skills used within service-centered work teams.
• Ability to read and assist as needed the creation of project-related drawings, sketches, or flowcharts.
• Strong proficiency in Microsoft Office suite of products and having experience with application software and equipment control systems hardware/software/firmware with the ability to navigate and document varied human-machine interfaces.
• Progressive experience in a related role within a cGMP environment with working knowledge of 21 CFR Parts 210, 211, 820 and 21 CFR Part 11.
  
  

Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings. 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!

Work Environment & Physical Requirements

This position requires extended periods of standing and walking on a manufacturing floor environment. Protective equipment (safety glasses, hearing protection, gowning) must be worn as required. The role operates in a temperature-controlled pharmaceutical manufacturing facility. Occasional lifting of up to 30 lbs may be required. Must be available to respond to critical shift issues outside of scheduled hours on an as-needed basis.

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.