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Director, Engineering & Technical Services
|Specific Duties and Responsibilities:|
We are a very dynamic specialty pharmaceutical company currently manufacturing over 100 million units using fully automated syringe lines. Now we are in our next progressive growth mode; aggressively developing ANDAs, NDAs for small molecules injectable product including peptides - solution, lyophilized product, suspensions, and liposomal formulations.
The position will support the development of a new, state-of-the-art manufacturing facility that will bring additional capacity for its injectable products packaged in liquid and freeze dried vials, syringes and bags.
The position will lead construction and start-up of a state-of-the-art manufacturing facility that will provide additional capacity for testing, formulation, fill and finish operations. The incumbent will provide construction management and facility operations perspective throughout the design, construction and CQV (commissioning, qualification and validation) phases of the program. The position will lead the staffing, development and management of the internal& external engineering, validation, technical services and maintenance staff and manage day to day operations once the facility is in commercial production. Responsible for compliance with all internal policies and external regulations governing construction execution and facility operations.
Education Minimum / Recommended:
Work Experience Required: