Jobs · Engineering · North Carolina

Sr Automation Engineer 1, MES

FUJIFILM Biotechnologies · Holly Springs, NC · 3 days ago
EngineeringFull-time

About the Role

The Sr Automation Engineer 1, MES provides support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support. Additionally, this role participates in designing and maintain the Manufacturing Execution System (MES).

What You'll Do

  • Spearheads the Automation team through activities, such as code configuration within several process areas and scope work using DeltaV
  • Leads the development for various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
  • Supports global alignment of our implemented capabilities, maintaining and protecting our global platform concept
  • Leads the development for various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
  • Plans and implements the technical direction for area of responsibility
  • Leads small teams through Automation changes and Tech Transfers
  • Makes complex decisions across single Automation systems
  • Contributes to Automation system hardware and software designs
  • Serves as on-call support for Automation inquiries and troubleshooting
  • Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
  • Conducts training and presents information to team or other stakeholders
  • Other duties, as assigned

Knowledge and Skills

  • Personal ownership and proactive collaboration with external business partners and internal stakeholders
  • Effective communication, both written and oral
  • Advanced problem-solving skills
  • Ability to effectively present complex information to others
  • Ability to provide feedback to others, including leaders
  • Ability to remain up to date on regulatory and quality requirements for manufacturing

Basic Requirements

  • Bachelor's degree in Chemical, Electrical, or Mechanical Engineering or other relevant field with 8 years of Automation, Instrumentation & Controls, or other relevant technical experience
  • OR Master's degree in technical field of study relevant to Automation or Instrumentation & Controls with 6+ years of Automation experience
  • Prior experience with MES that includes exposure to understanding behavior code, ET Configuration, EM configuration, DeltaV DCS configuration concepts, SC consumer execution group configuration

Preferred Qualifications

  • Prior experience and exposure to modelling BPR and eBR recipe components in a Manufacturing Executing System
  • Proficiency in the fundamental technologies used within DeltaV MES (Syncade), such as SQL Stored Procedures and xPath Matching
  • Previous experience within pharma/GMP experience

Working Conditions & Physical Requirements

  • Will work in environment which may necessitate respiratory protection
  • May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
  • Will work in environment operating a motor vehicle or Powered Industrial Truck
  • Ability to discern audible cues
  • Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
  • Ability to ascend or descend ladders, scaffolding, ramps, etc.
  • Ability to stand for prolonged periods of time (up to 30 minutes)
  • Ability to sit for prolonged periods of time (up to 240 minutes)
  • Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers
  • Ability to conduct work that includes moving objects up to 10 lbs. and 33 lbs.
  • Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions

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