Aseptic Process Validation Engineer I

Description: oSupports and collaborates with the project team for validation efforts right from inception, design build, test and implementation
oInvestigate/troubleshoot validation discrepancies for systems and/or performance processes
oSupport validation activities – IQ/OP/PQ
oSupport ethylene oxide requalification activities to meet ISO requirements on time
oCreate change controls and provide assistance in determining root cause for non-conforming events and evaluate CAPAs for effectiveness
oEnsures required processes and procedures are followed to support validation programs and are in compliance with regulations
oCo-operates with all departments through open, candid communication and collaboration
oPrior experience working with ethylene oxide and gamma sterilization processes
oPharmaceutical Industry GMPs. Interpret & Apply ISO 11135, 11137, TIR 15, TIR 28, 11737 and FDA and Country specific guidelines to the
medical devices and surgical.
oKnowledge of statistical analysis to assess control and manage risks of product quality and determine the responsibility for products or materials that do not meet required standards and specifications.

Custom Fields:
Name: Invoice Type
Value: USA-ARL-Staffing-USD

Name: Remote Worker
Value: No

Name: Work Desk Phone Number Required
Value: Yes

Name: System Access Required
Value: Yes

Name: Workspace
Value: None

Name: Badge ID Required
Value: Yes

Name: Worker Time Type
Value: Full Time

Name: Supervisory Org
Value: Quality Sterilization(Smita Gupta)-60000212