Gravity IT Resources
Manager, Validation - Aseptic Process Simulation
Gravity IT Resources, Richmond, Virginia, United States, 23214
Title:
Manager, Validation - Aseptic Process SimulationLocation:
Richmond, VAType:
Full-timeRelocation Assistance Available:
YesJob SummaryThe Validation Manager, Validation will support Aseptic Simulation Studies performing for Sterile Products and Bio-similar products at . 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 ResponsibilitiesDesign 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 Required for an InterviewBachelor'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.Direct Experience with sterile injectibles.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 QualificationsA post graduate degree is preferred.Experience with cleaning validation strongly preferred.Direct interaction experience with regulatory agencies.Company Summary:
Our client is a nonprofit pharmaceutical company founded in 2018, aimed at addressing drug shortages and providing essential medications at affordable prices. It focuses on manufacturing generic sterile injectables, particularly those used in hospitals. They collaborate with health systems and the government to ensure reliable access to critical medicines, helping to stabilize the supply chain and reduce dependence on expensive alternatives. The company prioritizes quality, reliability, and patient-centric outcomes in its production processes.
Manager, Validation - Aseptic Process SimulationLocation:
Richmond, VAType:
Full-timeRelocation Assistance Available:
YesJob SummaryThe Validation Manager, Validation will support Aseptic Simulation Studies performing for Sterile Products and Bio-similar products at . 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 ResponsibilitiesDesign 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 Required for an InterviewBachelor'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.Direct Experience with sterile injectibles.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 QualificationsA post graduate degree is preferred.Experience with cleaning validation strongly preferred.Direct interaction experience with regulatory agencies.Company Summary:
Our client is a nonprofit pharmaceutical company founded in 2018, aimed at addressing drug shortages and providing essential medications at affordable prices. It focuses on manufacturing generic sterile injectables, particularly those used in hospitals. They collaborate with health systems and the government to ensure reliable access to critical medicines, helping to stabilize the supply chain and reduce dependence on expensive alternatives. The company prioritizes quality, reliability, and patient-centric outcomes in its production processes.