System Specialist Andover, MA

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Unless specifically stated otherwise this role isOn-Site at the location detailed in the job post.


Use Your Power for Purpose

The System Specialist under Andover Site Technical Services (STS) Instrument Services (IS) provides technical support across instrumentation lifecycle activities in support of the Quality Control and Manufacturing Instrumentation Program at the Andover Massachusetts site.

The System Specialist will utilize their knowledge to provide technical support throughout the instrument lifecycle and support instrument qualification / upgrade operation and maintenance programs troubleshooting performance issue resolution reliability periodic review / System Health Check electronic data reconciliation administrative and decommissioning actions and deliverables for cGMP instruments and workstations used in the Quality Control Laboratories and GMP manufacturing suites. The System Specialist will also support technical and Continuous Improvement projects across the Site Technical Services Quality Control Laboratory and GMP Manufacturing team(s).

What You Will Achieve

In this role you will:

Support the Quality Control and Manufacturing Instrumentation Lifecycle Program and provide hardware and software installation configuration maintenance and troubleshooting support vendor and IQ/OQ/PQ support new system set-up back-up and restoration support kiosk mode software and Global Data Protection Solution installation activation and troubleshooting support and data virtualization support

Provide project management and technical support across instrumentation processes / programs troubleshooting and lifecycle activities and reliability / performance issue resolution actions

Make decisions to resolve moderately complex instrumentation issues and contribute to moderately complex instrumentation projects in collaboration with Quality Control and/or GMP Manufacturing Team(s)

Support validation / qualification / upgrade operation maintenance system administration reliability and/or decommissioning projects at the Andover site

Author and/or review routine to complex instrument documentation including (but not limited to) validation documentation operation and maintenance procedures system administration procedures instrument periodic review / System Health Check data integrity assessments electronic record assessments electronic data reconciliations decommissioning documentation Change Controls investigations and/or Corrective and Preventative Actions

Work under general supervision using own judgment where needed / appropriate