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Technical Source3 weeks ago

Process Automation Systems Lead

On-site · Wilson, North Carolina, United States

Type
Full Time
Level
Senior Level
Education
Not Specified
Company size
Unknown

Job Summary

Owner-side automation lead for the Buffer & Media Prep area in a large-scale biologics manufacturing startup, coordinating automation activities between Process Engineering, CQV, Manufacturing, and system integrators. Leads DeltaV Batch execution, process sequencing, FAT/SAT, commissioning, and startup activities; troubleshoots automation and sequencing issues within GMP systems; ensures alignment with site and global automation standards; collaborates with validation and quality teams to support GMP/CSV compliance; provides technical oversight of automation vendors and integration partners; supports the DeltaV automation strategy.

Required Qualifications

  • 6+ years of experience within pharmaceutical or biologics manufacturing environments
  • Strong Emerson DeltaV experience
  • DeltaV Batch experience within GMP manufacturing operations
  • Experience supporting biologics or pharmaceutical startup/commissioning activities
  • Understanding of ISA-88 / batch process sequencing concepts
  • Experience supporting Buffer & Media Prep or related bioprocess systems
  • Experience supporting FAT/SAT execution and issue resolution
  • Knowledge of: OSI PI
  • PLC systems
  • Industrial automation networks
  • OT infrastructure
  • 21 CFR Part 11
  • EU GMP Annex 11
  • GMP/CSV requirements
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Technical Source

Process Automation Systems Lead

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