Manager, Validation - Aseptic Process Simulation (362) - 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

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.