Validation Engineer II – (511) - Civica Rx

About Civica:

Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. “Race to the bottom” pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.

Who suffers most? Patients.

Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.

Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran’s Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been “Do What Is in the Best Interest of Patients.”

Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.

More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.

Long- and short-acting insulins will be produced and available in both vials and pre-filled pens – at no more than $30 per vial and no more than $55 for a pack of five pens.

Learn more about Civica’s plans and progress at  www.civicarx.org

Position Summary

The Validation Engineer II will be responsible for leading the commissioning, qualification, and validation (CQV) to support the commissioning, qualification, and validation of new and modified equipment, facilities, utilities, products, and processes in support of the project, operations, and quality objectives. Working closely with system owners and related stakeholders (Operations, Engineering, Laboratories, IT, and Quality Assurance).  This role will guide CQV activities to a compliant state throughout their lifecycle. This includes authoring, reviewing, and executing related CQV documentation as well as related documents for the role (e.g., procedures and change control records). Serves as subject matter expert for CQV activities.

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