Sr. Automation Engineer - Operations

Summary:  The Senior Automation Engineer - Operations provides technical support and accountability for the execution of operational activities that are critical to the success of our business. This position will also work closely with other departments to maintain automated systems and related quality requirements.

External US

Essential Functions:

• Support validation as Subject Matter Expert to ensure that appropriate regulations (e.g. 21 CFR Part 11 and cGMP) are addressed in validation in a development phase and level.
• Interfaces with IT to ensure GMP compliant integration with Corporate IT infrastructure.
• Provide support on a daily basis on BMS, SCADA, DCS, GMP controls, Utility Controls, Process Equipment PLC's, Utilities Equipment PLC's and GMP data archiving and retrieval.
• Maintain FS, SDDS and HDDS documents for automation systems.
• Develop, revise and maintain Automation SOPs, forms, documentation and files.
• Execute Software Test Specification.
• Maintain backups of automation code.
• Provide engineering and technical review of new equipment purchases, including Request for Quote Bid Packages, design review, FAT and SAT.
• Provide Subject Matter Expert (SME) function for CAPAs, Deviations and Change Controls.
• Create new and update existing maintenance procedures and spare part identification for automation systems.
• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation and industry codes.
• Knowledge of cGMP practices utilized in bulk drug and vaccine manufacturing environment.
• Performs other duties as assigned.

Required Skills & Abilities:

• Experience with Process Control System, SCADA design, implementation and operation required.
• Develop new code for continuous control and batch control required.
• Experience with critical utility and non-GMP utility systems a plus.
• Experience in automation related system commissioning and validation in GMP facilities is required.
• Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA.
• Computer knowledge of 21 CFR Part 11.
• Understand automation protocols like: HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC and Modbus TCP/IP.
• Experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, APOGEE, etc. preferred.
• Reliable, self-motivated individual with positive attitude; team-oriented with the ability to work with staff covering a variety of roles.
• Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities.
• Strong written, verbal and interpersonal communications skills and a strong attention to detail. Must be able to develop, draft and correct preventative maintenance procedures for technical equipment.
• Must be able to work effectively and efficiently with minimal supervision in a schedule-driven, ever-changing work environment.
• Working knowledge of MS Office products (Word, Excel, Outlook, and Power Point).
• Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility.

Working Conditions & Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  While performing the duties of this job, the employee is regularly required to:

• Experience prolonged sitting, standing, bending, stooping, climbing and stretching.
• Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
• The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
• Be exposed to noisy environments.

Qualifications:

• B.S. in Chemical, Electrical or Mechanical Engineering or equivalent with 5 years of relevant automation engineering experience in the biotechnology /pharmaceutical industry.

We are an equal opportunity and affirmative action employer. All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law.

If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3528.

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