... incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal ... enumeration, bacterial endotoxin (of support systems), and sterility (of in-process materials and finished ...

... incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal ... enumeration, bacterial endotoxin (of support systems), and sterility (of in-process materials and finished ...

... for supporting:** Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography ... complete routine calibration tasks, work with and troubleshoot complex process systems Contributes to the ...

... for supporting:** Process Equipment (e.g. tanks/bioreactors, filtration skids, chromatography ... ) Initiate and complete routine calibration tasks, work with and troubleshoot complex process systems ...

... regulatory filings Support Change Control documentation for complex process, validation, analytical ... required at times based on business unit needs and specific assignments. Specific assignments may be ...

... . Off-shift and weekend coverage will be required at times based on business unit needs and specific ... projects goals and deliverables related to the vaccine process. Lead validation studies and author the ...

... aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The ... -documented, while meeting timing commitments Lead in the identification and implementation of process ...

... aligning maintenance projects with the business objectives around Safety, Compliance and Cost. The Senior ... implementation of process improvement projects, productivity initiatives and corrective actions while focusing on ...

... . Maintains, cleans and prepares equipment used in production. Performs sampling/in-process testing supporting the manufacturing and validation process for current process. Provides timely delivery of ...

... activities that support cGMP and regulatory compliance during microbiological method transfer/qualification ... , method transfer/qualification reports, standard operating procedures, change controls, and investigations ...

... Purification manufacturing process for Bulk Drug Substance. Focused areas of responsibility include but are not limited to activities of: Tangential Flow Filtration, Chromatography, Homogenization, Process Monitoring ...

... safety, and regulatory requirements as written Works in a team environment to accomplish ... to business operations, in which case you may not be offered employment, or your employment could be ...

... of technology transfer process knowledge, post approval support, and post commercial process ... downstream purification process for the technology transfer of our Company's HPV vaccine drug substance ...

... , Animal Health) While Optimizing Our Base Business) Adapt | Develop Our People, Culture and Business ... laboratory areas, KPI reporting and facilitating regulatory audits. The individual in this role will provide ...

... . Provide support to all Quality related audits from external and regulatory agencies . Participate in Quality Risk Assessments and serve as QA SME Review and approve validation reports Identify ...