Specialist, Analytical Instrument Validation

Job description

Job Description The Pharmaceutical Analysis & Digital Technologies (PADT) External Capabilities, Validation, and Compliance (ECVC) department of our company Research Laboratories Division is seeking applicants for a Validation Specialist position available at either the Rahway, New Jersey research facilities. The Analytical Instrument Validation Specialist will work as part of the integrated Validation and Compliance team and drive a culture of quality and operational excellence across the global Development Sciences & Clinical Supply (DSCS) network. The Analytical Instrument Validation Specialist role oversees and/or supports the validation of novel computerized analytical instrumentation within the GMP environment for multiple sites (Pennsylvania, New Jersey, and Schachen, CH). The key responsibilities of this role will include: Partner with scientific teams across DSCS to drive compliance and operational excellence Validate novel and time-sensitive instrumentation in GMP environments to 21CFR11 compliance Support standardization activities for System Development Life Cycle globally Support internal quality and external regulatory audits and maintain laboratory state of permanent...