Validation Engineer II

3 days ago

Washington, Washington, D.C., United States Civica Rx Full time
About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to ensure that patients have access to essential medications at affordable prices.

We are a collaborative effort between health systems and philanthropies, with a team of experienced healthcare and pharmaceutical industry leaders. Our goal is to create a more sustainable and equitable pharmaceutical supply chain.

Job Summary

The Validation Engineer II will play a critical role in ensuring the quality and safety of our pharmaceutical products. This position will be responsible for leading the commissioning, qualification, and validation (CQV) of new and modified equipment, facilities, utilities, products, and processes.

The successful candidate will have a strong background in pharmaceutical manufacturing, with experience in sterile injectables, combination devices, or biologics. They will be responsible for authoring, reviewing, and executing CQV documentation, as well as related documents such as procedures and change control records.

Key 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.
  • Execute 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.
Requirements
  • 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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