Sterile Product Validation Manager

4 days ago

Washington, Washington, D.C., United States Civica Rx Full time
About the Role

Civica Rx is seeking a highly skilled and experienced Sterile Product Validation Manager to join our team in Petersburg, VA. As a key member of our manufacturing operations team, you will be responsible for leading Aseptic Simulation Studies for Sterile Products and Bio-similar products.

Key Responsibilities
  • Design and Develop Aseptic Process Simulation (APS) Program: Develop and implement a comprehensive APS program for Aseptic and Biosimilar injectables, ensuring compliance with regulatory requirements and industry standards.
  • Conduct Risk Assessments and Mitigate Risks: Identify and mitigate risks associated with aseptic processing operations, ensuring a safe and controlled environment for product manufacturing.
  • Manage APS Activities: Oversee APS activities for sterile injectable vials, cartridges, pre-fill syringes, and pens, ensuring timely completion and compliance with regulatory requirements.
  • Share Knowledge and Expertise: Collaborate with cross-functional teams to share knowledge and expertise on start-up and validation, including utilities and equipment.
  • Drive Enhancement of Sterile Standards: Develop and implement strategies to enhance sterile standards within the manufacturing environment, ensuring compliance with regulatory requirements and industry standards.
  • Investigate Deviations and Conduct Root Cause Analysis: Investigate deviations and conduct root cause analysis to identify and correct issues, ensuring compliance with regulatory requirements and industry standards.
  • Support Product Pre-Approval Inspection: Collaborate with regulatory agencies during site inspections, ensuring compliance with regulatory requirements and industry standards.
  • Understand and Implement Manufacturing Control Strategy: Develop and implement a manufacturing control strategy for various unit operation areas, ensuring compliance with regulatory requirements and industry standards.
  • Define Enabling Studies: Develop and implement enabling studies necessary for product submission, ensuring compliance with regulatory requirements and industry standards.
Requirements
  • Bachelor's Degree in Microbiology, Engineering, or Related Discipline: A bachelor's degree in microbiology, engineering, or a related discipline is required.
  • 8+ Years in Sterile cGMP Production Environment: A minimum of 8 years of experience in a sterile cGMP production environment is required.
  • Direct Experience with APS: Direct experience with Aseptic Process Simulation (APS) is required, including knowledge of Annex 1 and PDA technical reports.
  • Extensive Hands-on Experience: Extensive hands-on experience in the development of aseptic programs, including Clean Room Qualification and Environmental Monitoring, is required.
  • Strong Working Knowledge: A strong working knowledge of current standards and regulatory expectations for pharmaceutical product development, regulatory filing, and commercialization is required.

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