Senior Manager, CGT ITOT/Automation

Role Summary

The Senior Manager, CGT ITOT/Automation, reports to the AD, Process Automation and leads a team of site-based automation engineers to install, maintain and support automation systems primarily associated with Aseptic Drug Product equipment and facilities. Location: Durham, NC (On-Site).

Responsibilities

• Leads automation processes for the design, installation, maintenance and support of process equipment and automation systems.
• Continuously improves and seeks innovation related to site automation systems.
• Executes automation strategy and proper system management per global Novartis standards.
• Owns computerized systems for process related equipment.
• Manages engineers supporting 24/7 operations providing clear, consistent leadership, management and mentoring.
• Develops, monitors and improves KPI‚Äôs for system reliability.
• Change management and CAPA ownership to drive continuous improvement for automation systems.
• Leads SME‚Äôs for deviation investigations involving automation systems.
• Leads SME‚Äôs for automation systems in regulatory audits.
• Ensures training curriculum is optimized and ensures cross training of individuals across the team.
• Supports creation of standard lifecycle documentation, e.g., User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS), etc.
• Works closely with operations and manufacturing sciences to evaluate new product introductions and impact to automation systems.
• Supports the development of site facility and equipment master plans, network business processes associated with automation systems, and GTx Engineering initiatives or programs.
• Other related job duties as assigned.

Qualifications

• Bachelor of Science degree in Engineering or other relevant degree with 9 years of experience across multiple ITOT/Automation platforms, e.g., DCS, PLC, SCADA, MES, Historian, as well as experience with process equipment in the drug substance and drug product areas.
• Industry expertise in the design, reliable operation, modification, maintenance, and retirement of computerized systems.
• Demonstrated ability to work and collaborate on cross functional teams (QE, QA, validation, operations) in a fast paced, dynamic team setting.
• Strong interpersonal and excellent verbal and written communication skills are essential.
• Knowledgeable of health, safety and environmental regulations, and FDA (and similar) cGMPs.
• Planning, problem analysis, and decision-making skills.
• Proficient computer skill utilizing MS Office suite applications, Building Management Systems, and Computerized Maintenance Management Systems (CMMS).
• Self-motivated with a strong sense of ownership in areas of responsibility.