Sr Microbiologist, FGO QMS

What you will do:

• Oversight of environmental monitoring of cleanrooms in line with ISO 14644 standards, and monitoring of utilities including all grades of water, and where necessary, compressed air, bioburden and entoxin testing.

• Review/writing of cleaning protocols and reports in line with ISO 19227 standards

• Oversight of EtO sterilization processes. Validation and monitoring in line with ISO 11135

• Oversight of radiation sterilization processes. Validation and monitoring in line with ISO 11137

• Interpreting sampling and monitoring data, appliying statistical and analysis techniques, to determine control and trending. Indentifies and initiates when to take action.

• Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis.

• Act as technical lead for microbiology in cross functional groups including product and process issues, rootcausing, projects, initiatives and other business critical forums..

• Review of cleaning and sterilization validation files for compliance.

• Strong interactions, maintainance and support of sterile finished goods suppliers.

• Interact with Supplier quality team with respect to vendor sterilization topics.

• Performs sterilization release review, intepreting data and trends.

• Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving.

What you will need:

• Bachelor degree Microbiology or equivalent/ related subject required, with 6+ years Microbiology related experience

• Masters of Microbiology or equivalent related subject required, with 3+ years Microbiology related experience

• Experience of 6+ years in Quality/Regulatory Affairs environment.

• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.

• Thorough knowledge and understanding of US and International Medical Device Regulations and standards in area of expertise (Microbiology)

• Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.