System Specialist

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

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience Experience supporting software / hardware / computer systems and instrument lifecycle processes in a regulated environment

If You Have (Preferred Requirements)

• Experience validating, maintaining, and/or decommissioning quality control or manufacturing instruments
• Knowledge and practical application of relevant cGMP principles and industry standards as they pertain to instrument lifecycle and Data Integrity and ERES requirements (21 CFR Part 11, ICH, Annex 11)
• Proficiency with Network Technologies such as Virtual Network (VLAN), Network Security Protocols, and firewall technologies, familiarity with server components/configuration and virtualization systems, and experience troubleshooting Microsoft Operating System and components such as windows registry and system files

PHYSICAL/MENTAL REQUIREMENTS Ability to perform mathematical calculations, scientific computation, complex data analysis, verbal communication, written communication,…