Digital Plant Engineer (Automation)

i-Pharm GxP

Indiana

Hybrid

USD 83,000 - 152,000

Full time

13 days ago

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Job summary

i-Pharm GxP is seeking a Digital Plant Engineer for a hybrid, 2+ year contract in Central Indiana. The role bridges shop-floor automation with digital architectures, mapping data flows from DeltaV and PLCs to historians and Level 3 systems.

You will design batch traceability, parameter management, and data integrity solutions for MES and non-MES environments, aligning process recipes to ISA-88 logic. The position requires 5+ years of hands-on pharma automation experience, DeltaV expertise, and

Qualifications

  • Hands-on process automation experience in pharmaceutical/biotech API or clinical manufacturing.
  • Deep knowledge of DeltaV and batch control architectures; experience with Level 2/3 interfacing.
  • Strong understanding of ISA-88 batch structures and data integrity principles.
  • Ability to translate recipes into structured logic and data hooks for MES and non-MES environments.

Responsibilities

  • Bridge shop-floor automation to digital enterprise architecture.
  • Define data flows from equipment up to site historians and Level 3 systems.
  • Design batch traceability and parameter management for MES and non-MES operations.
  • Collaborate with process scientists and SI teams to align tagging and data capture.
  • Ensure compliance with cGMP, 21 CFR Part 11, and commissioning workflows.

Skills

Automation & DCS depth
ISA-88 Batch Standards
Level 2/3 Interfacing
Data architecture & CPPs
Compliance & Validation

Tools

Emerson DeltaV
DeltaV Studio
AVEVA PI / OSI-PI
MES platforms (Syncade, Tempo, PAS-X)
PLM tools (QbD Vision)

Job description

Digital Plant Engineer - Hybrid (1 week per month on-site) - Automation & Process Systems (Contract)

Are you a Process Automation / DCS Engineer who thrives on connecting the shop floor to digital architectures? We are seeking a Digital Plant Engineer for a multi-billion-dollar greenfield capital project delivering flexible, state-of-the-art GMP clinical trial drug substance facilities in Central Indiana.

This role is not a disconnected IT or high-level software position—we are looking for someone with a grass-roots automation and batch control background who can step into equipment-level discussions, map out physical data flows, and build the hooks between shop-floor control systems and Level 3 architectures.

  • Location: Hybrid – Central Indiana (Primary remote flexibility; 1 week per month on-site.
  • Duration: 2+ years contract.
  • Scope: Clinical trial drug substance manufacturing spanning small molecules, biologics, and novel modalities acoss multiple production buildings and lab-scale facilities.

The Role

  • Bridge Ground-Level Automation to Digital: Act as the critical translator between process scientists, automation PMO leads, on-site system integrators, and enterprise IT.
  • Define Data Flows from the Equipment Up: Map unit operation data flows from DeltaV, PLCs, and vendor-packaged skids up to site historians (AVEVA PI, Logmate) and Level 3 systems.
  • Design for Both MES and Non-MES Environments: Develop batch traceability, parameter management, and data integrity solutions for facilities operating both with full MES execution and those relying directly on DCS/historian capture on Day One (e.g., lab-scale/incubation suites).
  • Align Logic with Process Reality: Engage directly with process scientists to translate clinical recipes and operational workflows into structured ISA-88 phase logic, recipe templates, and equipment module requirements.
  • Collaborate with System Integrators: Guide and oversee on-site SI coding efforts to ensure control modules, communication hooks, and tag structures align with broader facility data architecture ahead of upcoming loop checks.

What We’re Looking For

  • Core Automation & DCS Depth: 5+ years of hands-on experience in pharmaceutical/biotech API or clinical manufacturing, with deep working knowledge of Emerson DeltaV (Batch, DeltaV Studio, Equipment/Control Modules).
  • ISA-88 Batch Standards: Comprehensive understanding of S88 batch structures (procedural models, phase logic, state transitions, and unit operations on physical assets like reactors and skids).
  • Level 2 / Level 3 Interfacing: Demonstrated track record defining tags, parameters, and hooks linking DCS layers to historians (AVEVA / OSI-PI), data lakes, or MES platforms.
  • Pragmatic Data Architecture Skills: Ability to look at a physical tank or lab instrument, understand what it is doing, and determine exactly how and where critical process parameters (CPPs) must be acquired and contextualized.
  • Compliance & Validation: Strong grounding in cGMP, 21 CFR Part 11, data integrity principles, and commissioning/qualification workflows.
  • Nice to Have: Prior exposure to MES platforms (e.g., Emerson Syncade, Apprentice Tempo, Werum PAS-X) and parameter management / PLM tools (e.g., QbD Vision).
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