Senior Automation Engineer (Pharmaceutical Manufacturing)

skellig-posted 4 months ago
Senior
Indianapolis, IN
101-250 employees
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Skellig is seeking a Senior Automation Engineer with DeltaV and cGMP experience to support our clients within the MidWest Region. As a DeltaV Automation Engineer you would need to support the system integration management for upstream equipment and systems in the areas of the Inoculum Lab, Media Preparation, Seed Culture, Large Scale Bioreactors, and Harvest contained within the Drug Substance Manufacturing (DSM) area of the facility. To be considered for this role you must have DeltaV experience and experience working in biotech/pharma.

  • Attend regularly scheduled project status meetings with the client
  • Provide design review and input on Automation requirements for one or multiple process areas
  • Attend and provide feedback during System Integrator functional reviews of certain process areas
  • Review life cycle documentation
  • Review and approve Kneat documents including: DeltaV software FATs, SATs, Automation Commissioning Test Protocols, software OQs, and Software Installation Verification protocols.
  • Support generation of Kneat documents.
  • Manage/oversee the System Integrator’s support of loop checks & commissioning activities for certain process areas
  • Coordinate with various project workstreams including FDBN Automation, FDBD Automation, CSV, CQV, Utilities, Process Engineering, and others as needed
  • 7+ years’ direct experience working with Emerson DeltaV DCS
  • Experience in a cGMP pharmaceutical facility working with FDA regulations is required
  • Working knowledge of Kneat validation software is required
  • Excellent organizational, oral, and written communication skills and fluency in English with the ability to effectively communicate within cross-functional teams and to management
  • Excellent interpersonal skills and ability to work effectively and efficiently in a team-based environment with employees at all levels
  • Ability to manage commitments while displaying an eagerness to learn and continuously improve
  • Knowledge with Drug Substance Manufacturing (DSM) would be beneficial
  • Vacation / Personal Paid Time Off
  • Sick Paid Time Off
  • Unlimited Unpaid Time Off
  • Paid Public Holidays
  • Parental Leave
  • Full Heath, Dental, and Vision PPO Insurance for you and any dependents - Premiums are 100% fully covered
  • Life Insurance and Accidental Death and Dismemberment
  • 401k + Match
  • Relocation Package
  • …. And more!
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