Sr Microbiologist, FGO QMS

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.

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.