The Automation and Control Engineer will be a part of the Process and/or Facility Operations team dedicated to supporting facility design, construction, commissioning, qualification and ongoing MEP/ Clean utility system operation, Maintenance and Calibration Programs and Engineering support including change control for facility and equipment.
This position is primarily responsible for Automation Engineering support of Cell and Gene Therapy MFG troubleshooting and optimization of stand alone, skid-based PLC automation systems on product manufacturing equipment, as well as Facility and Utility equipment. The individual will be expected to liaison with equipment vendors.
This individual will have the ability to understand and communicate Cell and Gene Therapy manufacturing process information in order to review the design of control systems and troubleshoot issues as they arise. The successful candidate will collaborate cross functionally to evaluate problems, document and recommend solutions, create change control and test plan paperwork, and implement approved changes. This person will support daily operations, commissioning, qualification and validation activities while working in cross-functional teams. The candidate will interface with GIS, Cell and Gene Therapy PD and GMP Manufacturing, Quality and Validation departments as well as functional area leads within Facility Operations including Maintenance, Metrology, EHSS, Planning and Scheduling and Lab support to provide timely and cost-effective automation solutions.
Additionally, this person will assist in design and implementation of an alarm notification and response strategy which will employ OSI PI or equivalent qualified monitoring and alarm notification system.
This individual will identify process control gaps and rectify them through an approved change control process.
The desired candidate will be responsible for version control for PLC programming and critical VFD parameter management as well as the qualified Facility Alarm response system including BMS and EMS. Candidates must understand P&IDs, wiring diagrams and I/O configuration, system networking and field devices including VFDs, as well as Ethernet networking and security.
The successful candidate will be working in a multidisciplinary cross-functional environment.
Key Responsibilities Include but are not limited to:
– Deliver automation and controls support for daily operations and troubleshooting on the cell and gene therapy PD and GMP Manufacturing equipment and other facility related stand-alone equipment
– Provide automation and controls expertise for delivery of cell and gene therapy manufacturing campaigns in a cGMP environment
– Use effective communication skills to provide process control options and strategies as part of a cross-functional team to improve system performance
– Develop and execute validation protocols
– Write technical reports and/or presentations relevant to processing activities and present to various levels of management and regulatory authorities
– Effectively multitask and demonstrate resourcefulness in running multiple activities concurrently
– A degree in chemical or electrical engineering or related field
– 7-10 years PLC programming experience, with progressive levels of responsibility and accountability.
– Experience with commissioning and validation of a pharmaceutical process is strongly desired.
– Experience with Honeywell, DeltaV, etc.
– Instrumentation and Controls experience
– Experience working with networked servers and clients, VMware, Remote Desktop, and interfacing with corporate IT is desired.
– Inventive and innovative, self-starter with a can-do attitude comfortable and successful working in undefined areas
– Experience in being a part of large matrix technical teams with collaboration, mentoring and shared responsibility for successful outcomes under accelerated timelines