Validation Engineer II Job at ClinLab Solutions Group, Petersburg, VA

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  • ClinLab Solutions Group
  • Petersburg, VA

Job Description

*******OFFERS RELOCATION ASSISTANCE*******

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

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