Specialist, IT & Manufacturing Systems Support (Off-Shift)
SacramentoOn-site
AI Summary
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs.
About this role
More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
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.
