Specialist Sterility Assurance Validation
Core
Responsible for cleanroom qualification, aseptic process simulation (Media Fills), and Annual Product Quality Reviews (APQR) for sterile injectable drug manufacturing.
Role type
Specialist Sterility Assurance Validation
Builds
Validated cleanroom environments and aseptic manufacturing processes for oncology therapeutics
Domain
Pharmaceutical manufacturing (sterile injectables, oncology)
Required skills
Cleanroom qualification, Aseptic process simulation (Media Fills), APQR creation, Risk analysis, Regulatory knowledge (GMP), Environmental monitoring, Hygiene, Microbiology
Preferred skills
Project management, Audit presentation, Validation offer creation
Technologies
Microsoft Office (Word, Excel, PowerPoint, Outlook)
Responsibilities
Plan, coordinate, execute, document, and evaluate cleanroom re-qualifications; Maintain and optimize cleanroom qualification systems; Create validation plans and reports; Conduct risk analyses; Manage aseptic process simulation systems; Generate annual reports with data visualization and trending; Represent department in audits and inspections; Address audit findings; Support validation offer creation
Seniority
Specialist, hands-on IC