Sr. Quality Engineer, Validations

Who you are

You have a strong background in quality engineering with a focus on validations, particularly in the pharmaceutical industry. With at least 5 years of experience, you understand the complexities of validation programs and are well-versed in FDA regulations such as 21 CFR Parts 210, 211, 820, and 11. Your expertise in managing validation and process qualification projects makes you a valuable asset to any team. You thrive in cross-functional environments, collaborating effectively with Quality, Operations, Engineering, and Maintenance teams to ensure that all systems operate in a state of control.

You possess a deep understanding of validation lifecycle management, including the development and execution of Validation Master Plans (VMPs) and User Requirement Specifications (URS). Your ability to lead Process Validation lifecycle activities, including Process Design and Continued Process Verification, showcases your commitment to maintaining high standards of quality and compliance. You are detail-oriented and have a strong focus on data integrity, ensuring that all validated systems meet the necessary guidelines and standards.

Desirable

Experience with ICH Q8/Q9/Q10 guidelines and GAMP 5 principles is a plus. Familiarity with risk-based validation approaches will enhance your ability to contribute to the team's success. You are proactive in identifying areas for improvement and are dedicated to strengthening process capability and enhancing equipment reliability.

What you'll do

In this role, you will take charge of the validation and qualification program management, developing and approving Validation Master Plans and associated documentation. You will lead the execution of validation activities, ensuring alignment with regulatory requirements and industry best practices. Your responsibilities will include authoring and reviewing Process Validation documentation, as well as managing the lifecycle of validation projects from initiation to completion.

You will collaborate closely with cross-functional teams to manage validation projects effectively, ensuring that all systems supporting pharmaceutical manufacturing remain compliant and operate efficiently. Your leadership will be crucial in driving process improvements and maintaining the integrity of the Quality Systems in place. You will also be responsible for training and mentoring junior team members, sharing your knowledge and expertise to foster a culture of quality within the organization.

What we offer

Revance provides a supportive work environment where you can grow your career in quality engineering. We value collaboration and encourage our employees to take initiative in their roles. You will have the opportunity to work on impactful projects that contribute to the success of our pharmaceutical manufacturing processes. We offer competitive compensation and benefits, along with opportunities for professional development and advancement within the company.