Senior Manager, CGT ITOT​/Automation

Job Description Summary

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.

This position will be located in Durham, NC and will be an On-Site role. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

• 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'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.

• 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.

The salary for this position is expected to range between $108,500 and $201,500 annually. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

#LI-Onsite

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e‑mail to us.reasonab or call  and let us know the nature of your request and your contact information.

Please include the job requisition number in your message.

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Api (Application Programming Interface), Api (Application Programming Interface), Automation, Back-End Development, Business Continuity, Change Control, Chemistry, Design Development, Electronic Components, General Hse Knowledge, Including Gdp, Java (Programming Language), Knowledge Of Capa, Knowledge Of Gmp,…