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Civica Rx · 7 hours ago

Validation Engineer II (543)

Petersburg, VA

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Civica Rx is a nonprofit organization focused on preventing drug shortages in U.S. healthcare. The Validation Engineer II will lead the commissioning, qualification, and validation activities for new and modified equipment and processes, ensuring compliance and supporting project objectives.

Pharmaceutical

H1B Sponsor Likely

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

Qualification

CQV experienceSterile injectables experienceRegulatory knowledgeValidation protocols authoringProcess improvement experienceAnalytical skillsInterpersonal skillsCollaborative skillsProblem-solving skillsLeadership skills

Required

Bachelor's degree in engineering or relevant sciences and 8+ years of CQV experience

8 years' experience with sterile injectables, combo-devices, or biologics

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

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

Company

Civica Rx

Glassdoor3.2

Civica Rx was created in late 2018 to secure the supply of important medicines hospitals use every day.

Founded in 2018

Lehi, Utah, USA

51-200 employees

https://civicarx.org/

H1B Sponsorship

Civica Rx has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (7)

2024 (2)

2022 (1)

2021 (2)