Quality Engineer I

Revance • Johnson City, TN

1d • 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. This role supports facility, utility, and equipment qualification and validation activities in compliance with cGMP requirements. The Quality Engineer I will develop, execute, and summarize validation documentation including validation plans, protocols (IQ/OQ/PQ), and final reports. They will also assist in the development and implementation of procedural and system controls to ensure repeatability and documentation of critical parameters. This role supports and/or initiates Change Controls, ensuring appropriate documentation, impact assessment, and compliance with quality system requirements. The Quality Engineer I executes testing protocols and procedures to support equipment and system qualification and ongoing control strategies. They collaborate cross-functionally with Quality, Operations, Engineering, and Maintenance to ensure timely completion of validation and quality-related project deliverables. The role supports deviation investigations, Nonconformance (NCM), and CAPA activities, including root cause analysis and effectiveness verification. They participate in risk assessments (e.g., FMEA, risk-based validation approaches) to support compliant and efficient validation strategies. The Quality Engineer I identifies and supports process improvements and troubleshooting activities for equipment and systems, ensuring alignment with quality and compliance requirements. They maintain accurate and complete documentation in accordance with cGDP and data integrity expectations.

Requirements

• Bachelor's degree in Scientific Discipline.
• 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.
• 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.

Nice To Haves

• Bachelor's degree in Engineering, or Bachelor's degree with suitable work history.
• Excels in compiling multiple forms of communications that describe the completed system.
• Must be available to respond to critical shift issues outside of scheduled hours on an as-needed basis.

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