Quality Engineer I

Revance • Johnson City, TN

9h • Onsite

About The Position

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.

Requirements

• Bachelor's degree in Scientific Discipline.

Nice To Haves

• 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.

Responsibilities

• 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 ensure repeatability and documentation of critical parameters
• Support and/or initiate Change Controls, ensuring appropriate documentation, impact assessment, and compliance with quality system requirements
• Execute testing protocols and procedures to support equipment and system qualification and ongoing 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 support compliant 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

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: Entry Level
• Number of Employees: 251-500 employees