Our client, a leading pharmaceutical company, is hiring a Site Integration – Cell Therapy Manufacturing Systems on a contract basis.
The IT Site Integration engineer – Cell Therapy Manufacturing Systems, supports the successful operation of manufacturing and business functions at multiuse sites through interaction with internal team members, peer and higher level customers as well as external service providers. The individual is responsible for development of and adherence to system governance procedures. The individual supports multiple IT projects/systems and ongoing work activities of moderate to high complexity. The individual will answer questions and resolve IT issues for manufacturing and manufacturing support staff.
The candidate should have at least 5 years of experience in pharma/biotech with specific understanding in Supply Chain, Manufacturing and Quality System disciplines. The candidate needs to have an understanding of shop floor activities, Good Manufacturing Practices (GMPs), and process automation in addition to prior experience in IT Systems and Network.
• Ability to effectively communicate with both technical and non-technical team members.
• Ability to effectively understand complex environments and work with different teams to understand integration challenges and provide solutions.
• Ability to clearly lay out the technical challenges of integration and provide guidance on best approaches
• Strong interpersonal skills, especially regarding:
• Teamwork and collaboration
• Client focus
• Verbal and written communication
• Knowledge of Cell Therapy Facility (CTF) IT Architecture and IT Infrastructure including Networks, Servers, HMIs, Printers, Scanners, Switches, Firewall rules, Domains, etc.
• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
• Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
• Strong technical and problem-solving skills and the ability to work independently.
• Demonstrated success working in a high-performing, business results-driven environment.
• Knowledge of Cybersecurity, patching and IT Life Cycle Management (LCM).
• Understanding of computer system validation. • Bachelors degree in an engineering or MIS discipline or commensurate experience.
• Must have experience with Windows server migrations (server 2016 and above), Microsoft AD, Azure SSO, Ping.
• Working knowledge of network concepts, VMware Horizon view, Citrix Xen Desktop VDI, File servers (Netapp and Nugenesis).
• Understanding of manufacturing applications such as OSI PI, MES, Unicorn, etc.,
• Understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g. Oracle, SAP).
• Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
• Sound understanding of a Cell Therapy manufacturing facility IT Architecture and IT Infrastructure including Networks, Servers, HMIs, Printers, Scanners, Switches, Firewall rules, Domains, etc.
DUTIES AND RESPONSIBILITIES:
• Work with different Site leads and application owners to understand the impacts of domain migration of applications and define a solution and way forward for the integration.
• Own the integration of applications and work with multiple teams to successfully migrate/integrate applications between domains.
• Be the CTF IT Business Analyst point of contact and own the analysis and integration definition of multiple cell therapy applications.
• Work on cell therapy instrument/equipment integration with different domains and applications.
• Define the Disaster Recovery/HA for applications migrated over to other domains and schedule testing.
• Accountable for uninterrupted 24/7 operations of manufacturing systems for CAR-T manufacturing.
• GXP, GAMP, SDLC regulations
• VMware Horizon view, Citrix Xen Desktop VDI, File servers (Netapp and Nugenesis)