Pharma Automation Engineer - GMP, CSV & MES

Shoolin Inc

North Carolina

On-site

USD 85,000 - 125,000

Full time

13 hours ago
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Job summary

Shoolin Inc. is seeking an Automation Engineer to support a greenfield pharmaceutical manufacturing facility focused on API production.

You will oversee end-to-end automation activities from design through startup, coordinating with engineering, QA, IT and external vendors. The role requires 2–5 years in pharma automation, strong GMP experience, and hands-on exposure to MES, BMS, historian systems, and PLC/DCS platforms such as Emerson DeltaV or Rockwell.

Qualifications

  • 2-5 years pharma automation experience preferred.
  • Strong experience in GMP manufacturing environments.
  • Familiar with CSV/GAMP concepts and regulated systems validation.
  • Hands-on exposure to MES, BMS and historian systems.
  • Experience with PLC/DCS platforms such as Emerson DeltaV or Rockwell/AB.
  • Involvement in capital projects, preferably greenfield pharma facilities.
  • Experience supporting FAT, SAT, commissioning, and startup activities.
  • Strong documentation of automation design deliverables (I/O lists, system architecture, specs).
  • Ability to work with cross-functional teams including engineering, QA, IT and vendors.

Responsibilities

  • Support automation design activities including strategies, narratives, system architecture, and I/O definitions.
  • Assist in automation project execution across design, build, commissioning, and startup phases.
  • Coordinate with internal teams and external vendors for system design and implementation.
  • Support validation planning and execution for GMP compliance.
  • Participate in FAT, SAT, commissioning, and startup readiness activities.
  • Track project milestones, risks, and dependencies and escalate issues as needed.
  • Ensure compliance with GMP, data integrity, safety, and cybersecurity standards.
  • Prepare project updates, dashboards, and leadership presentations.

Skills

GMP environments
CSV / GAMP concepts
MES / BMS / Historian systems
PLC / DCS platforms

Tools

Emerson DeltaV
Rockwell/AB
MES
BMS
Historian systems

Job description

Shoolin Inc. is seeking an Automation Engineer to support a greenfield pharmaceutical manufacturing facility focused on API production.

You will oversee end-to-end automation activities from design through startup, coordinating with engineering, QA, IT and external vendors. The role requires 2–5 years in pharma automation, strong GMP experience, and hands-on exposure to MES, BMS, historian systems, and PLC/DCS platforms such as Emerson DeltaV or Rockwell.

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