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 escal [iet?] complex problems to the appropriate system administrators. 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 escal[ate] 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. 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. Compensation & Benefits The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote‑based positions, this range may vary based on your local market. Full‑time employment positions will also be eligible to receive pre‑IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on‑site locations. Legal Notice We’re proud to be an equal‑opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. #J-18808-Ljbffr Orcabiosystems