Provide advanced level of technical automation support and troubleshooting to the manufacturing team.
Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines
Lead implementation of new PLC/HMI engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment and software design, commissioning, protocol review, and testing to meet end user requirements
Provide input to system specifications, user requirements, functional requirements, and system design specifications
Will lead the transitioning of new automated systems being developed in R&D into manufacturing and sustain them over time.
Execute necessary testing and qualification protocols as related to the overall design and performance of automated process and monitoring equipment
Design, develop, and implement software/hardware improvements to automated process control products
Develop and execute test plans for software/hardware improvements
Implement new computer imaging technology into the manufacturing area
May provide training or presentations on basic automation systems to manufacturing team members.
Develop and draft standard operating procedures and automation engineering documents
Communicate effectively with engineering staff and cross functional departments
Education and/or Work Experience Requirements:
Advanced skills with programming and troubleshooting PLCs, HMIs, and computerized system design, installation, and support in a cGMP industrial setting
Expert in PLC/HMI logic programming and troubleshooting Allen-Bradley and Siemens products which involve the use of batch programming (S-88), data acquisition, and PID control
Demonstrated knowledge of electrical systems, instrumentation and controls
Strong knowledge of process control and machine automation in biotech or pharmaceutical manufacturing facility
Expertise in developing and editing Software Lifecycle Documentation, engineering design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines
Strong written and verbal communication skills with ability to delegate tasks
Proficiency with standard business software is required (Word, Excel, etc.)
Able to balance changing priorities with increasing workload by making timely decisions
Able to interact with employees at all levels and cross functionally across multiple departments
Ability to manage and develop direct reports through mentoring and leadership
BS in Engineering or related field and 5 years of experience in the design and maintenance of process control systems and/or data acquisition systems
Equivalent relevant experience in the design and maintenance of process control systems and/or data acquisition systems may be considered in lieu of a degree
Specific knowledge of Allen-Bradley and Siemens control system products is required
Direct experience in a pharmaceutical or biopharmaceutical manufacturing facility is preferred
