About Civica:

Critical shortages of essential generic injectable drugs are an ongoing crisis in U.S. healthcare and have reached an all-time high. Over 300 essential medications are currently reported to be in shortage, according to industry and FDA reports.

Shortages put patients at risk and waste hospital resources.

Civica is a market-based nonprofit solution created in 2018 by health systems and philanthropies for the express purpose of preventing and mitigating drug shortages. Today, nearly 60 health systems have joined Civica, representing over 1,400 hospitals and approximately one-third 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 with essential medicines. Civica currently supplies medicines to health system members in 49 states.

Civica’s mission has expanded beyond the hospital setting to reach consumers directly through CivicaScript, which is dedicated to making quality outpatient generic medicines affordable and available. CivicaScript works with trusted manufacturing partners to develop quality generic medicines and has forged partnerships with like-minded payors, pharmacy benefit managers and pharmacies to enable significant cost savings to be passed along to their customers.

Civica’s new 140,000 square foot state-of-the-art manufacturing facility in Virginia will soon produce a steady supply of more than three dozen sterile injectables, all drugs that are currently in or near shortage. The plant will also produce affordable biosimilar insulins, ensuring all Americans have access to lower cost, quality insulins, regardless of their insurance status.

The Civica Foundation is a 501(c)(3) organization that fosters philanthropic support for Civica’s work to manufacture and distribute affordable medications. The Foundation’s first commitment is to support Civica’s efforts to bring affordable insulin to all Americans. Leaders from nearly every corner of the diabetes ecosystem are partners in this initiative.

Civica is leading a movement for patients, not profits. Because eliminating shortages and stabilizing high prices are in the best interest of patients.

Join us. Learn more at www.civicarx.org

Position Summary

The Associate Validation Engineer will assist in the commissioning, qualification, and validation (CQV) of new and modified equipment, facilities, utilities, products, and processes in support of projects, 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).

The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Essential Duties and Responsibilities:

• Execute validation activity as defined by approved protocols and test plans. Where applicable, this includes operating equipment or executing the process which is being validated.
• Perform relevant testing or evaluation during validation and document the results into validation protocols.
• Create detailed and meticulous records during validation activity meeting GMP standards.
• Investigate and troubleshoot validation problems as they occur.
• Complete validation activity in coordination with other related groups (e.g., manufacturing, engineering, or testing labs).
• Understand and apply the understanding of FDA and Quality System Requirements in carrying out duties.
• Support 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.

Basic Qualifications and Capabilities:

• A minimum of an associate’s degree in a relevant technical field is required (e.g., engineering, biology, chemistry, etc.). Bachelor's degree is a plus.
• 2+ year’s progressive experience in a manufacturing, quality, technical, or validation role at a pharmaceutical manufacturing / distribution facility, with at least 2 years of validation activity.
• Experience working in cGMP environments that meet FDA, ICH guidelines, local regulations, and industry best practices.
• 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.
• Exposure to 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 with regulatory inspections is preferred.
• Experience in a sterile fill-finish facility.
• Start-up experience preferred.
• Knowledge or experience with technical documentation such as P&ID, wiring diagrams, and schematics preferred.
• Experience with validation tools and processes, including temperature mapping and use of Kaye Validator.

Physical Demands and Work Environment:

The physical demands described here are representative of those that an employee must meet to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug-free workplace, and complies with ADA regulations as applicable.