Process Hygiene Lead
Core
Lead and execute Process Hygiene activities across Biologics Manufacturing, covering Central Services, Cell Culture and Purification, serving as the subject matter expert for contamination control and aseptic practices.
Role type
Senior IC Process Hygiene Lead (Biologics Manufacturing)
Builds
Contamination control systems, aseptic practices, and process hygiene initiatives for biologics manufacturing operations.
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Contamination control, Aseptic techniques, FMEA, Root-cause analysis, CAPA, Change control, SOP governance, Data trending, Gemba assessments, Cross-functional collaboration
Preferred skills
Regulatory inspection support, Statistical tools, Environmental monitoring data analysis
Responsibilities
Lead contamination and cross-contamination FMEAs and process hygiene assessments; Provide SME for contamination event investigations and CAPA; Drive contamination risk-reduction and inspection-readiness initiatives; Review microbial and environmental-monitoring data to identify emerging risks; Assess aseptic techniques via floor observations and provide coaching; Partner with QC, Engineering, and Facilities to address hygiene risks; Translate regulations into site procedures and training; Maintain shop-floor presence and communicate trends to stakeholders.
Seniority
Senior, hands-on IC