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Early Stage C&Q Engineer – CQ Execution

Job in Indiana, Indiana County, Pennsylvania, 15705, USA
Listing for: i-Pharm GxP
Full Time position
Listed on 2026-02-06
Job specializations:
  • Engineering
    Quality Engineering, Process Engineer, Test Engineer, Validation Engineer
Job Description & How to Apply Below
Location: Indiana

We are supporting an early-stage C&Q program on a capital project in Indiana and are seeking a hands-on C&Q Engineer to support CQ execution development, protocol standardisation, and commissioning readiness
.

This is a fully onsite role (5 days per week) and will suit someone comfortable working closely with Commissioning, CQ Verification, and Site QA teams during Start-up and Shakedown activities.

Key Responsibilities
  • Report directly to the CQ Verification SME
  • Assist in revising and updating project SOPs
  • Support the creation of gold-standard execution examples for:
  • Start-up
  • Shakedown
  • Operational Verification (OV)
  • Align with Site QA on:
  • How execution examples are to be performed
  • How execution evidence and documents are attached to protocols in KNEAT
  • Assist in training commissioning teams on protocol execution expectations
  • Support periodic reviews of CQ protocol executions to ensure consistency and compliance
Required Experience
  • Background in C&Q / CQV / Validation within GMP environments
  • Hands‑on experience with protocol execution (IV/OV, Start-up, Shakedown)
  • Experience authoring or revising SOPs and execution protocols
  • Strong understanding of GMP documentation and data integrity
  • Comfortable working onsite 5 days per week in Indiana
  • Able to work closely with QA and Commissioning teams
Nice to Have
  • KNEAT experience (authoring, execution, attachments)
  • Commissioning or start‑up project exposure
  • Experience creating execution templates or standards
  • Greenfield or early‑stage CAPEX project experience
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