Automation Sr Manager

Novartis•Durham, NC

8d•Onsite

About The Position

The Senior Manager Automation, reports to the Site ITOT Head and leads a team of site-based automation engineers to install, maintain and support automation systems primarily associated with a new Drug Substance facility. Location: This position will be located in Durham, NC and will be an onsite role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you. Key Responsibilities: Leads automation processes for the design, installation, maintenance and support of process equipment and automation systems for a new drug substance facility. 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’s for system reliability. Change management and CAPA ownership to drive continuous improvement for automation systems. Leads SME’s for deviation investigations involving automation systems. Leads SME’s 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.

Requirements

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 drug substance process equipment.
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.

Responsibilities

Leads automation processes for the design, installation, maintenance and support of process equipment and automation systems for a new drug substance facility.
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’s for system reliability.
Change management and CAPA ownership to drive continuous improvement for automation systems.
Leads SME’s for deviation investigations involving automation systems.
Leads SME’s 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.