Responsibilities:
- Own and manage the IT shared landscape across the Cell Therapy site IT systems (IT Architecture and IT Infrastructure including Network, Servers, HMIs, Printers, Scanners, Switches, Firewall rules, Domains, etc.).
- Serve as the CTF IT Cybersecurity Point of Contact (POC) and own the system patching effort for local IT systems.
- Monitor, track, and reduce ServiceNow tickets related to IT Infrastructure.
- Manage spares and inventory for IT Infrastructure.
- Support Disaster Recovery of local computerized systems and act as main POC during P1 and P2 ServiceNow tickets.
- Ensure uninterrupted 24/7 operation of manufacturing systems for CAR-T Manufacturing.
Requirements:
- Bachelorβs degree in engineering or MIS.
- Experience with Cybersecurity, patching, and IT Life Cycle Management (LCM) in a bio-tech manufacturing environment.
- 4+ years of hands-on experience in biotech manufacturing and supply chain.
- Understanding of supply chain/manufacturing domains and supporting tech, including manufacturing and supply chain ERP systems (e.g., Oracle, SAP).
- Working knowledge of regulatory requirements (primarily GDPs) and how they relate to business systems.
- Sound knowledge of Cell Therapy manufacturing facility IT Architecture/Infrastructure (Networks, Servers, HMIs, Printers, Scanners, Switches, Firewall rules, Domains, etc.).
- Ability to communicate with technical and non-technical team members.
- Strong teamwork/collaboration, client focus, and verbal/written communication.
- Knowledge of cGMP, GXP, GAMP, SDLC (including 21 CFR Part 11) and good documentation practices.
- Knowledge of pharmaceutical/manufacturing/lab systems supporting biologics and clinical manufacturing.
- Strong technical/problem-solving skills; ability to work independently.
- Demonstrated success in a high-performing, business results-driven environment.
- Understanding of computer system validation.