Manager, Validation - Aseptic Process Simulation (362)

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

Job Description:

The Validation Manager, Validation will support Aseptic Simulation Studies performing for Sterile Products and Bio-similar products at Civica Rx, Petersburg. This role will be responsible for leading Aseptic Simulation studies from early planning, building strategies in a collaborative manner across internal disciplines and external partners and contractors. 

Essential Duties and Responsibilities:

• Design and develop the Aseptic Process Simulation (APS) program for Aseptic and Biosimilar injectables.
• Conduct risk assessments and mitigate risks associated with aseptic processing operations.
• Consider multiple factors in the design of APS studies including Bracketing / Definition of Simulations / Interventions, clean room Staff qualification, Risk Base determination of Interventions, Microbiological Investigations and Environmental Monitoring as Part of the Media Fill, Incubation, Assessment and Evaluation.  
• Manage the APS activities for sterile injectable vials, cartridges, pre fill syringes, and pens.
• Share knowledge and expertise with respect to start up and validation including utilities and equipment.
• Drive enhancement of sterile standards within the manufacturing environment. Resolve complex problems by applying sound sterile operation principles, utilizing knowledge from FDA & European regulatory guideline, PDA and Annex 1 requirement.
• Investigate Deviations and conduct Root Cause Analysis.
• Understand the scientific principles for manufacturing parenteral drug products, device assembly and packaging, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Support product preapproval inspection. The role has direct interaction with regulatory agencies during site inspections.
• Understand and implement manufacturing control strategy for various unit operation areas.
• Define enabling studies necessary for product submission and conduct those internally and externally with collaboration from different departments.

Basic Qualifications and Capabilities:

• Bachelor's degree in microbiology, engineering, or a related discipline.
• 8+ years in a sterile cGMP production environment.
• Direct experience with APS including knowledge of the requirements of Annex 1 and PDA technical reports.
• Must have extensive hands-on experience in the development of aseptic programs including Clean Room Qualification, and Environmental Monitoring.
• Experience with biological production processes.
• Strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization.

Preferred Qualifications:

• A post graduate degree is preferred.
• Experience with cleaning validation strongly preferred.
• Direct interaction experience with regulatory agencies.

Position ID: 362

Shift: Day Shift. Monday through Friday.