Job Description

Main Responsibilities and Accountabilities: List the roles and responsibilities of the position.

1Responsible for providing engineering expertise to support the design, installation, commissioning, validation and operation of the automation systems.

2Accountable 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 PMs, BOMs 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

3 Provides technical expertise for all phases associated with the automation system, providesimprovements based on supporting data, technical knowledge, engineering principles and current industry practices.
4 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 (CAPAs and OOTs) 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 (GEMBAs/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.

5 Responsible to ensure control system data integrity and user friendly navigation with alarm rationalization strategic implementation for efficiency in alarm response.

6 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.

7 Perform and document hardware/software modifications and system functional specification updates in Collaboration with Execution Systems. 8 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.

9Complies with requirements from Clients Safety Program, including Health and Safety mandates and OSHA requirements.

10Completes any other duties/responsibilities assigned by senior management.

Position Qualifications and Experience Requirements:

Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.

Education

Bachelors Degree in Electrical or Mechanical Engineering preferred or B.S. degree in an Engineering related field.
Experience

• 3+ years of relevant automation/controls experience and a BS
• 2+ years of relevant experience and an 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 Systems (Johnson Controls, Siemens, Honeywell, Rockwell, or others) 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