Early Stage C&Q Engineer – CQ Execution
Job in
Indiana, Indiana County, Pennsylvania, 15705, USA
Listed on 2026-02-06
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
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
- 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
- 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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