Associate Director Sterility Assurance

Civica Rx • Petersburg, VA

9h

About The Position

Civica is searching for an Associate Director – Sterility Assurance to support the growth and operational readiness of its Petersburg, VA facility, which will be the first generic drug product facility in the US to use all isolator-style high-speed filling lines. This individual will serve as a site-level technical leader responsible for establishing, executing, and continuously improving the sterility assurance control strategies that underpin Civica's aseptic manufacturing operations, including the Civica Affordable Insulin program <civicainsulin.org>. The Associate Director – Sterility Assurance will work closely with cross-functional site teams including Manufacturing, Quality Assurance, Engineering, and Regulatory Affairs to ensure that sterility assurance programs are robust, compliant, and fit for purpose for a high-speed parenteral manufacturing environment. This role reports to senior technical leadership and serves as the primary site SME for sterility assurance, supporting inspection readiness, investigations, and the continuous development of site capability — all in service of Civica's mission to "Do what's in the best interest of patients."

Requirements

• Bachelor's degree inMicrobiology, Biology, Pharmaceutical Sciences, or a related disciplinerequired.
• Minimum 10+ years ofexperience in parenteral sterility assurance, environmental monitoring, orequivalent roles within a highly regulated pharmaceutical manufacturingenvironment.
• Deep technical knowledgeof sterility assurance science and compliance, including current regulatoryexpectations for aseptic processing, contamination control, and environmentalmonitoring.
• Hands-on experience withisolator or RABS barrier system technology in a parenteral manufacturingsetting.
• Demonstrated ability tolead microbiological investigations, perform root cause analysis, and developeffective corrective and preventive actions.
• Strong working knowledgeof applicable regulatory guidance including FDA Aseptic Processing Guidance, EUGMP Annex 1, and relevant USP chapters.
• Excellent written and oralcommunication skills, with the ability to present complex technical topics tocross-functional teams and regulatory agencies.
• Strong data analysisskills, attention to detail, and ability to make sound technical decisions in adynamic manufacturing environment.
• Ability to mentor anddevelop scientific talent in the field of sterility assurance and appliedpharmaceutical microbiology.
• Demonstrated ability towork cross-functionally and influence peers and stakeholders to advancetechnical and quality objectives.

Nice To Haves

• Master's degree or PhD ina biological science preferred.
• Experience supportinggreenfield or new facility start-up activities, including the establishment ofsterility assurance programs from the ground up.
• Familiarity withhigh-speed aseptic filling operations and isolator-based manufacturingenvironments.
• Experience participatingin FDA or other health authority inspections as a sterility assurance SME.
• Exposure to Annex 1 (2022)implementation and contamination control strategy development.
• Experience working in oralongside a network technical function or supporting multi-site sterilityassurance program harmonization.

Responsibilities

• Establish, implement, andcontinuously improve site-level sterility assurance control strategies,including environmental monitoring, contamination control, personnelqualification, and aseptic process simulation programs, in alignment with cGMPregulations and current industry guidance (e.g., USP, EU Annex 1, FDA AsepticProcessing Guidance).
• Serve as the primary siteSubject Matter Expert (SME) for sterility assurance, providing technicalguidance to Manufacturing, Quality, and Engineering functions on mattersrelated to aseptic operations, contamination control, and microbiological riskmanagement.
• Lead and supportmicrobiological and sterility assurance investigations, including OOS/OOTresults, environmental monitoring excursions, and media fill failures, drivingthorough root cause analysis and the development of effective CAPAs.
• Support the design,qualification, and start-up of aseptic filling lines and associated barriersystems (isolators), ensuring sterility assurance requirements are incorporatedinto facility and equipment design from the outset.
• Develop, author, andreview GMP documentation including SOPs, validation protocols, technicalreports, contamination control strategies, and risk assessments in support ofsite operations and regulatory submissions.
• Lead and coordinateAseptic Process Simulation (media fill) programs, including design, execution,evaluation, and trending of results.
• Drive the development andmonitoring of the site Environmental Monitoring program, including datatrending, alert/action limit setting, and program effectiveness reviews.
• Support regulatoryinspection readiness and participate in health authority inspections (e.g.,FDA) as the site SME for sterility assurance, preparing relevant documentationand responses.
• Participate in externalindustry forums, technical conferences, and regulatory working groups to staycurrent with emerging guidance and best practices in sterility assurance,bringing relevant learnings back to the site.
• Build and developsite-level sterility assurance capability by mentoring and providing technicalguidance to junior scientists and cross-functional team members.
• Collaborate with networkand corporate technical functions to ensure site programs are aligned withbroader organizational standards and best practices, while maintaining aprimary focus on Petersburg site needs.
• Maintain a safe workenvironment and support all applicable Health, Safety, and Environmental (HSE)goals and requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level