Validation Engineer II

Validation Engineer II—Prince George County, Virginia

• Essential Duties and Responsibilities:Lead the development and execution of commissioning, qualification, and validation protocols for various equipment and systems.
• Responsible for all phases of the CQV activity, including requirements gathering, validation planning, protocol generation, test execution, configuration documentation, and system release.
• Executes validation activity in a timely manner, planning and proactively pursuing details to ensure project completion without avoidable delays.
• Evaluate System Change Controls for Validation Impact. Support Change Qualification through the creation of relevant Change Actions.
• Support the development of Standard Operating Procedures for new processes and equipment.
• Interpersonal skills to manage interactions and achieve results across a range of functions within the site. It may also extend to external communication with system vendors.
• Serve as Principal Investigator for validation-related excursions.
• Contribute to the continuous improvement of validation processes and procedures.
• Basic Qualifications and Capabilities:Bachelor’s degree in engineering or relevant sciences and 8 years of CQV experience.
• 8 years’ experience with sterile injectables, combo-devices, or biologics.
• Advanced degrees or certifications relevant to the role is a plus.
• Knowledge of regulatory requirements (cGMP, FDA, etc.).
• Experience authoring, approving, and executing validation protocols for major pharmaceutical manufacturing facilities, utilities, and equipment.
• Self-directed with problem-solving, analytical, and technical skills.
• Ability to think strategically and tactically (detail-oriented).
• Strong collaborative and influencing skills and ability to work well in a cross-functional, matrixed environment.
• Ability to lead, take ownership, and follow through on assigned projects.
• Demonstrated ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
• Experience in a process improvement environment, including change management and participating in Lean/Six Sigma project teams.
• Ability to work autonomously within established guidelines, procedures, and practices.

• Preferred Qualifications:Experience in a sterile fill-finish facility.
• Experience with single-use components in drug product formulation, sterile filtration, and aseptic filling applications.
• Start-up experience preferred.
• Experience with validation tools and processes, including temperature mapping and use of Kaye Validator