Contamination Control Specialist
Core
Maintaining microbiological control in utility systems and manufacturing environments to ensure product sterility and quality.
Role type
Senior Contamination Control Specialist (Pharmaceutical Manufacturing)
Builds
Sterile biologics and vaccines
Domain
Biopharmaceutical manufacturing / Sterility Assurance
Required skills
Risk assessment, CAPA management, GMP compliance, Environmental monitoring, Data trending, Validation protocols, Regulatory inspections, SOP development, Cross-functional collaboration, Shop floor oversight
Preferred skills
Quality Assurance, Quality Control, Manufacturing Technical Support, Facilities Engineering, Automation, Project management, Trackwise system, Analytical instrumentation
Technologies
Trackwise, Analytical instrumentation
Responsibilities
Conduct risk assessments for contamination control, Lead investigations into contamination failures and propose CAPA, Oversee site activities and performance for contamination control systems, Ensure presence on the shop floor to oversee practices and identify gaps, Review monitoring data to propose improvements, Participate in audits and regulatory inspections, Support validation protocols and projects, Advise cross-functional teams on best practices
Seniority
Senior, hands-on IC