Assoc. Director of Controls Engineering - Pharmaceutical

Summary:

The Associate Director, Controls Engineering provides is a highly technical individual providing strategic leadership and operational accountability over the company’s entire automation philosophy and program development. This includes defining the composition of the Operational Technology (OT) network, developing operational and maintenance procedures and defining hardware and software specifications for all manufacturing and facilities equipment. 

This role ensures that controls and computer - based systems across the organization are designed, implemented, and maintained in compliance with regulatory requirements and aligned with business objectives that include efficiency to support scaling operations. 

This position leads controls engineering activities supporting manufacturing, facilities, maintenance, and capital projects, ensuring adherence to Good Engineering Practices (GEP) and current Good Manufacturing Practices (cGMP), while driving innovation, process improvement, and operational excellence. 

This role will define strategies to maintain compliant systems in accordance with all applicable regulations and industry guidance including CFR 21 part 11, Annex 11, EU GMP, PIC/S PI-041 and GAMP 5 covering system integrity, data integrity, audit trail reviews and user role development and access management. 

This role will work hand in hand with the Validation and Quality Assurance teams to achieve a robust end to end program.