Automation Engineer

We are a global biotechnology leader, motivated by that same promise to save and improve lives. We offer the broadestrange of qualityplasma-derived and recombinant therapies in our industry. We discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. We are looking for an Automation Engineer

The Automation Engineer is responsible for oversight of operational and troubleshooting support for the utilities Automation System with strict adherence to Standard Operating Procedures (SOPs) and cGMP's in a Pharmaceutical Manufacturing facility. Will provide plant engineering support for projects as it relates to the utility control system and demonstrate skills in design, configuration, integration, implementation, and qualification of automation control solutions with integration to OSI-Pi historian.

This individual will work closely with a cross-functional team to meet the needs of the groups they support.

Responsibilities:

• Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the automation systems.
• Accountable for the Utility Automation Reliability Program:
• Execute the maintenance strategy for new and modified equipment
• Management of CMMS data integrity and execution of Reliability Centered Maintenance Improvements
• Develop preventative maintenance procedures for automation systems ensuring maintenance programs are implemented
• Continuous Improvement of maintenance PM’s, BOM’s and Spare Parts
• Review and lead equipment replacement as part of the life cycle improvement process and continuous improvement initiative planning.
• Implements and monitors predictive maintenance of the system
• Oversees reconditioning of the equipment to restore to like-new condition
• Performs upgrades to improve safety, operational performance, and extend operational life
• Collaborates with local and global partners to develop asset management plan that includes capital Requests
• Provides technical expertise for all phases associated with the automation system, provides improvements based on supporting data, technical knowledge, engineering principles and current industry practices.
• Ensure cGMP compliance of all automation systems to meet regulatory compliance:
• Equipment is maintained at a level required to provide high reliability maximizing useful life
• Review environmental monitoring and laboratory sample release test results
• Manage deviations, investigations (CAPA’s and OOT’s) with on-time closure
• Safely resolve process problems, improve efficiency, reduce waste, and maximize uptime production
• Execute root cause analysis around equipment and operational events, owning change controls, investigations
• Lead investigations as the subject matter expert providing technical expertise for all phases associated with the operation and troubleshooting of the automation systems
• Responsible for the development and maintenance of the control drawings, flow diagrams and Standard Operational documents.
• Perform inspections for quality assurance on a periodic basis and initiate any procedures necessary to resolve problems
• Responsible for inspections (GEMBA’s/audits) for quality assurance on a periodic basis.
• Responsible for change control activities, the implementation of CAPA items, quality investigations and determine/implement long lasting corrective actions and preventative measures.
• Responsible to ensure control system data integrity and user friendly navigation with alarm rationalization strategic implementation for efficiency in alarm response
• Support all aspects of Johnson Controls Metasys for Validated Environments software configuration tools and Rockwell Automation Control Systems. Understands coordination and communication protocols between platforms such as Allen Bradley, MODBUS, BACNet, etc.
• Perform and document hardware/software modifications and system functional specification updates in Collaboration with Execution Systems.
• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to biopharmaceutical industry engineering best practices and technologies, as well as technical understanding/problem solving capability.
• Complies with requirements from our Safety Program, including Health and Safety mandates and OSHA requirements.
• Completes any other duties/responsibilities assigned by senior management.

Qualifications:

• B.S. degree in an Engineering related field.
• Strong programming/design “hands-on” experience with Building Automation System (Johnson Controls, Siemens, Honeywell, Rockwell, or other) and SCADA systems is required.