Automation Engineer II

FUJIFILM Diosynth Biotechnologies U.S.A., Inc. is seeking a full time Automation Engineer II with a concentration in DELTA-V distributed control system (DCS) from Emerson. This position will deliver the planning and execution of small, medium, and large projects in support of process automation equipment and systems utilizing the DELTA-V DCS.

Reporting to the Sr. Automation Manager, this engineer is responsible for programming, debugging, and field troubleshooting automation equipment with DELTA-V controllers. This engineer shall have experience on all modules of the DELTA-V system and proven knowledge on components like DELTA-V Control Studio, Cascade Control, Delta-V Operate Configure, Theme Dynamos, and familiar with the PK, M series, S series, and Charms line of controllers.

This engineer will support equipment migration from ABB 800xA over to the DELTA-V DCS to include working with vendors and contractors to upgrade the infrastructure and put in place new procedures to support DELTA-V.

Essential Duties and Responsibilities

Management

  • Interface and build collaborative partnerships with key site functions including Manufacturing, Technical Operations, Engineering, and Quality to deliver site goals and objectives.
  • Actively support automation engineering projects.
  • Provide training or presentations on DELTA-V systems.

Performance

  • Maintain and support manufacturing automation DELTA-V systems
  • Maintain 100% customer satisfaction for all technical support calls.
  • Provide hands-on detailed diagnostics/troubleshooting support for automated process control and monitoring systems
  • Support the design and implementation of sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBU standards and cGMP regulatory requirements while following GAMP guidelines
  • Support capital projects with an automation element from conception, design and initial specifications through completion and turnover.
  • Develop/Revise User Requirement Specifications, Functional Specifications, Design Specifications, and Guidelines for new and existing control systems
  • Develop, revise and abide by standard operating procedures and automation engineering documents.
  • Lead, support, and perform investigations relating to complex manufacturing deviations and anomalies associated with automation systems and control system software in order to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence
  • Other duties as assigned

Requirements

Technical

  • Controls
    • Experienced DELTA-V programmer.
    • Working knowledge in OSI-PI.
    • Basic knowledge of a variety of automation software applications, process control, Ladder Logic, PLC
  • Regulatory
    • Basic knowledge of IQ/OQ/PQ requirements in a regulated industry
    • Basic knowledge of FDA regulation 21 CFR Part 11
    • Knowledge of Data Integrity on FDA regulated environments.
    • Knowledge of compliance industry regulations (cGMP, GxP, 21 CFR Part 11, GAMP, SOX and ISO)

 

Education and Experience

  • B.S. Degree in Chemical, Electrical, Mechanical, or Computer Engineering with 3+ years’ experience of relevant process automation or
  • 7+ years’ equivalent process automation work experience

 

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

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