Lead Specialist, Sterilization and Microbiology - Exton, PA

Lead Specialist, Sterilization and Microbiology

Exton, PA

The Lead Specialist, Sterilization and Microbiology will support the maintenance of all sterilization activities for Biomedical manufactured products, the execution of site contamination control policies and procedures, managing environmental monitoring program, 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 will work in partnership with Supplier Quality Assurance team to drive continual improvement in the sterilization processes and services of Biomedical Exton’s sterilization providers. 

Key Responsibilities:

• Responsible for supporting sterilization activities performed on products manufactured at site, including dose audits and EO requalification assessments
• 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. 
• Serve as support for supplier compliance to company sterilization sciences and biological safety systems and standards including authoring and reviewing validations and product adoptions into existing processes. 
• 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 Program and Controlled Environment qualification activities, and implement and maintain adherence to Controlled Environment policies and procedures 
• Support/perform test method validations for lab related testing such as bioburden or endotoxin testing
• Support disposition and correction steps of NCR processes as necessary or required in the microbiology, sterilization, and product safety function
• Perform gap analyses of any applicable standards and ensure dsm-firmenich continued compliance and conformance to these standards
• Support viral inactivation studies risk assessments as related to viral safety 
• Support execution of annual zoonosis reports and literature reviews for animal derived product 

We Bring:

• A competitive compensation package, with comprehensive health and welfare benefits
• A place to grow and develop
• A company that is purpose-led and performance-driven in a corporate culture that values people and planet
• The opportunity to work on growing brands and build on a strong foundation
• The chance to make improvements and make an impact on the business

You Bring:

• Bachelor’s degree in Biological science with experience within the medical device/pharmaceutical industry
• 3-5 years experience in QA/QC, preferably within the scope of microbiological control in Medical Device/Pharmaceutical Manufacturing 
• Sterilization experience (gamma, Ebeam, EtO), required
• Environmental monitoring, nice to have
• Clean room experince, nice to have
• Quality standards ISO13485 & MDD 
• Sterilization related standards: ISO 11137, ISO 11135
• FDA Regulations & Guidelines, 21CFR820, GMP 
• Excellent knowledge of quality management systems  
• Change management/processes  
• Knowledge of systems: Microsoft Office, SAP, & Document Management Systems 

The Lead Specialist, Sterilization and Microbiology operates in a quality environment which is highly regulated. Advanced understanding of cGMP, ISO, USP, AAMI etc. standards is required.  The role will interact with external auditors and external/internal customers.  Thorough understanding of multiple device sterilization methods and requirements essential.  Good statistical knowledge as related to Quality Assurance.