Sr. Automation Engineer
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: November 22, 2021
Overview Summary:-- The Senior Automation Engineer provides
technical support and accountability for the execution of capital
projects that are critical to the success of our business. The
Senior Automation Engineer will participate in the development,
installation, operation, maintenance, and repair of all FUJIFILM
Diosynth Biotechnologies Texas automation systems to meet
organizational goals and objectives. This position will also work
closely with other operators, calibration technicians and engineers
to maintain complex systems. External US Essential Functions:
- Support validation as the 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.
- Interface with IT to ensure GMP compliant integration with
Corporate IT infrastructure.
- Prepare, assist, and participate in system, specification
development, and design.
- Provide support on a daily basis on Building Management Systems
and Process Control Systems.
- Coding, programming, and configuration for continuous and batch
- Responsible for DeltaV Batch recipe configuration, phases, EMs,
- Develop procedures to transfer technologies, recipes,
parameters from process development to commercial
- Responsible for the DeltaV Virtualization.
- Responsible for the OSI Soft PI Historian configuration and
- Maintain Functional Specifications, Database Design
Specifications and Hardware Design Specifications for automation
- Develop and maintain Automation Standard Operating Procedures
and training for Automation Systems.
- Perform Engineering Test Plans for Automation.
- Support, configuration and maintain automation reporting
systems like Infobatch.
- 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.
- Perform all job duties and responsibilities in a compliant and
ethical manner and in accordance with all applicable laws,
regulations and industry codes.
- Responsible for ensuring compliance with cGMP practices
utilized in bulk drug and vaccine manufacturing environment.
- Performs other duties as assigned.Required Skills & Abilities:
- Knowledge in Manufacturing Enterprise System including Weight
and Dispense and EBR.
- Experience with Process Control System, SCADA design,
implementation and operation of systems.
- Develop new code for continuous control and batch control.
- BMS, SCADA and DCS design, commissioning and validation in GMP
- 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
- Experience with DCS, SCADA and BMS systems such as DeltaV,
Factory Talk View, APOGEE, etc.
- 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
- Must be able to work effectively and efficiently with minimal
supervision in a schedule-driven, 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.
- Support company manufacturing activities 24/7.
- Attendance is mandatoryMinimum Qualifications:
- Bachelor---s Degree preferably in Chemical, Electrical,
Mechanical Engineering or closely related field with five (5) years
of relevant automation engineering experience preferably in the
biotechnology /pharmaceutical industry; ORPreferred Qualifications:
- Experience with critical utility and non-GMP utility systems a
plus.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 e-mail FDBTHR@fujifilm.com or call
Keywords: FDBT - FUJIFILM Diosynth, College Station , Sr. Automation Engineer, Engineering , College Station, Texas
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