FUJIFILM Cellular Dynamics, Inc · 13 hours ago
Automation Engineer 2, MES (Syncade)
Holly Springs, NC, US
Full-time
Onsite
Entry, Mid Level
2+ years expFUJIFILM Cellular Dynamics, Inc is building the future of bioproduction in Holly Springs, North Carolina. The Automation Engineer 2 provides support to the Drug Substance Manufacturing facility, focusing on implementing changes to automation systems and maintaining the Manufacturing Execution System (MES).
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Performs Automation activities, such as code configuration, document development, and test execution within several process areas
Delivers accurate and on-time Automation work
Creates standard code utilizing medium complexity control strategies
Participates in designing and maintaining the global MES platform to accommodate for new capabilities
Assesses requirements and needs identified during Technology Transfers (TT) and participates in the implementation
Ensures good manufacturing practice (GMP) integrity of MES is maintained
Collaborates with senior Engineers to develop (generate, review, maintain) various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
Collaborates with senior Engineers to develop (generate, review, maintain) various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
Serves as on-call support for Automation inquiries and troubleshooting
Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
Other duties, as assigned
Qualification
Required
Bachelor's degree in Chemical, Electrical, or Mechanical Engineering or other relevant field
2 years of Automation, Instrumentation & Controls, or other relevant technical experience
Effective communication, both written and oral
Strong problem-solving skills
Ability to effectively present information to others
Ability to interpret and demonstrate knowledge of an Automation subject area to internal partners
Proficiency in the fundamental technologies used within DeltaV MES (Syncade), such as structured query language (SQL) Stored Procedures and xPath Matching
Knowledge of modeling Batch Production Record (BPR) and electronic Batch Record (eBR) recipe components in MES
Performs Automation activities, such as code configuration, document development, and test execution within several process areas
Delivers accurate and on-time Automation work
Creates standard code utilizing medium complexity control strategies
Participates in designing and maintaining the global MES platform to accommodate for new capabilities
Assesses requirements and needs identified during Technology Transfers (TT) and participates in the implementation
Ensures good manufacturing practice (GMP) integrity of MES is maintained
Collaborates with senior Engineers to develop (generate, review, maintain) various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
Collaborates with senior Engineers to develop (generate, review, maintain) various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
Serves as on-call support for Automation inquiries and troubleshooting
Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
Preferred
3+ years of DeltaV MES (Syncade) experience (including exposure to behavior code, equipment tracking (ET) and event monitor (EM) configuration, basic DeltaV distributed control system (DCS) configuration concepts, SC consumer execution group configuration)
Previous experience within a pharmaceutical or GMP environment
Company
FUJIFILM Cellular Dynamics, Inc
Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.
51-200 employees
H1B Sponsorship
FUJIFILM Cellular Dynamics, Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (4)
2021 (1)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
Blake Anson
Senior Director - Discovery Research Partnering
Ilyas Singec
Chief Scientific Officer
Recent News
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