Sr. Automation Engineer
Company: FDBT - FUJIFILM Diosynth
Location: College Station
Posted on: January 12, 2021
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Job Description:
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 controls.* Responsible for DeltaV Batch recipe configuration,
phases, EMs, CMs.* Develop procedures to transfer technologies,
recipes, parameters from process development to commercial
manufacturing.* Responsible for the DeltaV Virtualization.*
Responsible for the OSI Soft PI Historian configuration and
maintenance.* Maintain Functional Specifications, Database Design
Specifications and Hardware Design Specifications for automation
systems.* 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 facility.* 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.* 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, 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; OR* Associates Degree
preferably in Chemical, Electrical, Mechanical Engineering or
closely related field with eight (8) years of relevant automation
engineering experience preferably in the biotechnology
/pharmaceutical industryPreferred Qualifications:* Experience with
critical utility and non-GMP utility systems a plus.
Keywords: FDBT - FUJIFILM Diosynth, College Station , Sr. Automation Engineer, Other , College Station, Texas
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