Reliability Automation Engineer

The Reliability 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.

Role that this position reports to: Sr. Manager, Reliability Engineering

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 CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.

• Completes any other duties/responsibilities assigned by senior management.

Qualifications:

• Bachelor’s Degree in Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field.

• 3+ years of relevant automation/controls experience and a BS

• 2+ years of relevant experience and a MS
• Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc.)
• Strong programming/design “hands-on” experience with Building Automation System (Johnson Controls, Siemens, Honeywell, Rockwell, or other) and SCADA systems is required.
• Experience configuring, troubleshooting and using Windows Operating Systems, Networking, virtualization and Databases for Control System Applications
• Experience with data historians (like OSI-PI), MS-SQL and reporting tools are required.
• Working knowledge of Control and Instrumentation for facility control systems. Basic knowledge of programmable logic controllers (PLCs), instrumentation (e.g., flow, pressure, temperature, level) and controls is required.
• Working knowledge of pharmaceutical process sanitary connections, valves and supply loops.
• Experience with Quality Management and Change Control Systems.
• Knowledge of computerized maintenance management systems (CMMS).
• Excellent problem-solving skills and the ability to work in collaborative and independent work situations and environments with minimal supervision.
• Demonstrated ability to manage contractors, while interfacing with multiple departments, working with internal customers to manage projects.
• Knowledge of manufacturing processes
• Computer skills: MS Project and AutoCAD preferred

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.