Senior Microbiology and Product Safety Specialist (Exton, PA)

Senior Microbiology & Product Safety Specialist 

Exton, PA

(Hybrid - on-site 3 days a week)

 

The Senior Microbiology & Product Safety Specialist will support the maintenance of all sterilization activities for dsm-firmenich manufactured products,  the execution of site contamination control policies and procedures, providing input to the design of manufacturing processes related to microbiological control, and in producing reports  as related to the biosafety of newly developed animal derived products (e.g. viral inactivation  studies, zoonosis reports). This role works in partnership with Supplier Quality Assurance team to drive continual improvement in the  sterilization processes and services of dsm-firmenich sterilization providers. 

 

At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work to not only benefit our People, Customers & Communities but also drive business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.

 

Key Responsibilities:

• Manage and maintain corporate internal and sub-contracted testing programs for assurance of patient safety including sterile product release and contamination control.
• Serve as technical liaison to internal and external laboratory microbiological testing functions including performing audits of the contract facility utilizing international  regulatory standards as well as ISO 13485.
• Coordinate supplier compliance to company sterilization sciences and biological safety systems and standards including authoring and reviewing validations and product adoptions into existing processes.
• Assist Regulatory Affairs in the performance of activities related to product evaluation for use in product registration related to microbiological safety.
• Participate in the review and approval of new processes and changes to existing processes both internally and at supplier-based locations to ensure maintenance of microbiological control.
• Oversee the Environmental Monitoring Pro