Assoc Dir, Engineering

Novartis is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and to enhance the quality of life. We also seek to provide a return to shareholders that reflects our performance and to adequately reward those who invest ideas and resources in our company.

Associate Director, Engineering (Process)

Reporting to the Director of Engineering, provides managerial direction and technical leadership for the engineering, startup, commissioning and qualification of all process systems and clean utilities to support fermentation, purification, formulation and filling for a new Cell Culture based Flu Vaccine manufacturing facility to be located in Holly Springs, NC.

Major Accountabilities:The incumbent will be an integral member of an owner facility design, construction and validation management team. Management duties include all aspects of personnel, facility and equipment management of a large scale Vaccine Bulk manufacturing facility. Provides direct supervision of the process engineers responsible for Bulk, Fill Finish and Clean Utility operations. Sets department policy regarding staffing, hours and job functions to meet the needs of the planned projects and production. Works on problems of complex scope and plays a key role in troubleshooting problems in Bulk, Fill Finish and Clean Utility operations. Coordinates with Maintenance regarding non-GMP utilities design, spare parts and design for maintainability. Works with QA/Compliance group for GMP certification of the facility and equipment. Writes and reviews GMP documents like Validation Protocols, Standard Operating Procedures and Batch Process Records. Responsible for preparing and managing the departmental budget. Presents work updates at project and other meetings.

REQUIREMENTS: BS Mechanical or Chemical Engineering from an accredited university. Minimum 12 years related industry experience required. 8+ years experience in pharmaceutical/biotech operations, with thorough working knowledge of cGMPs, FDA regulatory guidelines, and validation principles required. Design experience or owners experience in process utility systems including purified water, WFI, CIP, SIP, compressed air and waste treatment. Working knowledge of the process for fermentation, purification and formulation required. Strong leadership, organizational planning and project management skills, in addition to technical knowledge, is required to coordinate multi- disciplinary teams. Excellent interpersonal effectiveness and communication skills (written and oral) are required in order to interface across management levels and departments. Experience with project design, construction, start-up, commissioning and validation as well as supporting factory acceptance tests and site acceptance tests required. This position will be based in Holly Springs, NC, but will require regular travel to Cincinnati, OH and Philadelphia, PA as well as equipment vendors during the design and construction process. Some travel to other Novartis sites including Marburg, Germany and Liverpool, UK will be required.Novartis Vaccines & Diagnotics is a new division of Novartis consisting of two businesses focusing on the development of preventive treatments and tools. Novartis Vaccines is the world's fifth largest vaccines manufacturer and second-largest of flu vaccines in the United States an equal opportunity employer.