Specialist, IT & Manufacturing Systems Support (Off-Shift)

Position Summary:

The Specialist, IT & Manufacturing Systems Support is a hybrid role designed to ensure 24/7 operational continuity for our manufacturing facilities. This individual will serve as the frontline technical resource during night and weekend shifts, handling Level 1 and Level 2 IT helpdesk troubleshooting (such as Okta lockouts and basic system routing) while also being trained to execute electronic Batch Record (eBR) building and document updates within MasterControl.

We are looking for a technically savvy, detail-oriented individual who can follow strict protocols, troubleshoot system access issues, and escalate complex problems to the appropriate system administrators.

Essential Duties & Key Responsibilities:

• Provide Level 1 and Level 2 troubleshooting for critical manufacturing applications (e.g., TrakSYS, MasterControl, and enterprise systems) during graveyard and weekend shifts.
• Resolve urgent issues that are impacting the manufacturing process such as access issues, password lockouts, workflow restarts, and label printing issues.
• Triage, document, and escalate complex hardware or software issues to corresponding Tier 3 IT or system owners when immediate resolution is not possible.
• Support weekend and off-shift activities as part of a 24/7 coverage model, with specific shift availability required for weekends (10:00 PM - 6:00 AM) and weekdays (6:00 PM - 6:00 AM).
• Act as an off-shift drafting and testing resource for electronic Batch Records (eBR), following explicit, structured directions to update step references and system parameters.
• Assist with basic, standardized tasks within the MasterControl Manufacturing Excellence (MX) and Quality Excellence (QX) modules.
• Serve as off-shift MasterControl Administration and Document Control owner to ensure production documentation moves seamlessly through the pipeline. E.g., process MC tickets including account creation, termination and role assignments.
• Support data entry and system routing tasks per established Good Manufacturing Practices (GMP) and data integrity guidelines.
• Occasionally provide on-site hardware or system troubleshooting at the manufacturing facility during weekend shifts if needed, though routine work can be managed remotely.

Required Qualifications:

• Technical Savviness: 2+ years of experience in an IT Helpdesk, Technical Support, or Systems Support role (Level 1/2 troubleshooting).
• Shift Flexibility: Ability to work non-traditional hours, specifically overnight shifts (10:00 PM - 6:00 AM / 6:00 PM - 6:00 AM) and weekends (Saturday/Sunday).
• Process-Driven Mindset: Exceptional attention to detail with the ability to follow rigorous, step-by-step technical instructions for resolving technical issues and updating system configuration and eBRs.
• Systems Familiarity: Experience with identity management/SSO tools and IT ticketing systems.
• Label Printing: Experience troubleshooting label printing software (e.g., Bartender) and hardware (e.g., Brady, Zebra) issues.
• GMP Awareness: Prior experience working within a regulated GMP manufacturing environment is highly preferred, but a strong understanding of compliance, data integrity, and 21 CFR Part 11 requirements is required.
• MasterControl/MES Experience: Prior experience with MasterControl (MX/QX modules) or MES system (e.g. TrakSYS) is a plus, but not required. Comprehensive training on basic MasterControl administration and eBR writing will be provided.