Quality Assurance Engineer II - Facilities and Equipment (350)

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

Job Description

The Quality Engineer II will join the Civica, Inc. (“Civica”) Quality organization at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica’s new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications.

Responsibilities of the position include maintaining quality systems and oversight to ensure the validation/qualification and operation of process, facility, utilities, equipment, and computer systems meet cGMP and Civica compliance requirements at the onset of building the facility, leading to successful U.S. Food and Drug Administration (FDA) approval of the facility and the ongoing introduction and approval of new medications.

Responsibilities also include, but are not limited to, the generation, review, and/or approval of policies, procedures, reports, and other records necessary to provide quality oversight of Civica Engineering functions, including validation, qualification, and ongoing operation activities of facility, utilities, processes, equipment, instrumentation, and to ensure FDA requirements are met.

Essential Duties and Responsibilities:

• Working across functional groups to ensure the site’s quality system processes related to GMP compliance of the facility, equipment, computer systems, and processes.
• Work with validation and engineering teams to provide Quality oversight for validation and qualification activities and ensure work is performed in a compliant and controlled manner.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality-related matters is provided to the site.
• Support and ensure compliance of facilities and utilities validation, and requirements from and/or to other manufacturing sites.
• Support implementation and quality oversight related to the overall compliance of the facility, equipment, and manufacturing processes.
• Support quality processes and systems across the product lifecycle, including, but not limited to, change control, CAPA, deviations and investigations, label control, laboratory control, product quality complaints, Annual Product Quality Review (APQR), and management notification. 
• Provide quality review and support for pest control program, calibration, and maintenance programs, and ensure they are run in accordance with GMP regulations.
• Lead or participate in Quality Risk Management and analysis.
• Proactively identify and work collaboratively to resolve problems by taking risk-based and compliant approaches to solutions.
• Promote a quality mindset and quality excellence approach to all activities.
• Promote a safety mindset and focus on safety for all operational activities.
• Travel (up to 5%) may be required.

Basic Qualifications and Capabilities:

• Bachelor’s degree in a scientific discipline with a minimum of 6 years of Quality/cGMP experience in the pharmaceutical industry.
• Experience in facility and equipment qualification, process validation, LIMS systems, and calibration and maintenance programs.
• Knowledge in 21CFR Part 11, Electronic Records and Signatures, and data integrity is required.
• Strong project management, organization, and execution skills to manage multiple projects and priorities.
• Participation and leading activities to support regulatory agency inspections required.
• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
• Ability to work autonomously and within established guidelines, procedures, and practices.
• Serve as a Quality subject matter expert to support driving investigations to the root cause.
• Leverage experience and share industry best practices to support continuous improvement of site procedures.
• Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
• Continuously looking for opportunities to learn, build skills, and share knowledge with others.
• Excellent interpersonal and written communication skills and experience using various software/electronic applications required.

Preferred Qualifications:

• Experience across the product development and commercialization lifecycle, including change management and associated implementation strategies.
• Technical expertise in sterile pharmaceutical isolator technology, combination product and medical devices. 

Physical Demands and Work Environment:

The physical demands described here are representative of those that an employee must meet to perform the essential functions of this position successfully. Reasonable accommodation 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 is frequently required to use their 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 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

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