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Tech Lead Sterilization

2 months ago

tamil nadu, India L&T Technology Services Full time
We are hiring for L&T Technology Services - Tech lead Sterilization
Prior experience with sterilization technology and/or sterilization methods
Experience within the Life Sciences or medical device industries
Location - Chennai /Bangalore
Experience - 10 yrs to 13 yrs
Medical device quality systems and sterility assurance requirements
DMAIC and/or lean manufacturing principles
Equipment and product design and validation experience
Familiarity with radiation, heat, filtration, and chemical sterilization methods and associated international standards (ISO 11135, ISO 14937, ISO 11137, ISO 13408)
Working knowledge of microbiological testing, biocompatibility and associated international standards (ISO 11737, ISO 11138, ISO 14161, ISO 10993) required to support sterilization process validation
Review the changes requested by Supplier for process changes, Equipment changes, line transfer, material sourcing change
Define the PPAP requirements and other site specific requirement for the change
Prepare draft PPAP and Co-ordinate with supplier for the evidence and regulatory/FDA requirements
Review various PPAP documents received from supplier (PFD, PFMEA, PCP, Validation documents, Process capability study reports, etc) and validate against the process or part requirements
Review process validation plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Coordinate with internal stakeholders/SME's to obtain approval and route it to respective stakeholders.
Work with Sterility assessment, bio burden SME's to close as per site requirement based on type of change
Co-ordinate with Change analyst to close the ECN/ECR's after appropriate approval
Communicate SICR owners & Site SPOC on the status of each SICR's and ETA.
Medical device quality systems and sterility assurance requirements
DMAIC and/or lean manufacturing principles
Equipment and product design and validation experience
Familiarity with radiation, heat, filtration, and chemical sterilization methods and associated international standards (ISO 11135, ISO 14937, ISO 11137, ISO 13408)
Working knowledge of microbiological testing, biocompatibility and associated international standards (ISO 11737, ISO 11138, ISO 14161, ISO 10993) required to support sterilization process validation
Review the changes requested by Supplier for process changes, Equipment changes, line transfer, material sourcing change
Define the PPAP requirements and other site specific requirement for the change
Prepare draft PPAP and Co-ordinate with supplier for the evidence and regulatory/FDA requirements
Review various PPAP documents received from supplier (PFD, PFMEA, PCP, Validation documents, Process capability study reports, etc) and validate against the process or part requirements
Review process validation plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Coordinate with internal stakeholders/SME's to obtain approval and route it to respective stakeholders.
Work with Sterility assessment, bio burden SME's to close as per site requirement based on type of change
Co-ordinate with Change analyst to close the ECN/ECR's after appropriate approval
Communicate SICR owners & Site SPOC on the status of each SICR's and ETA.