Overview
Intellectt is looking for Medical Device Quality Assurance professional for W2 contract role onsite at Massachusetts. Senior Commissioning / Startup Engineer — 5–10 Years. Location: Onsite – Indianapolis. Industry: Pharma (Capital Projects / Utilities / Automation). 6-12 Months.
Responsibilities
- Lead commissioning and startup execution for pharma utility and process systems.
- Develop and review operation verification (OV/OQ) test scripts, startup logic, and turnover strategy.
- Lead startup activities including flushing, pressure testing, system energization/livening, and readiness reviews.
- Oversee installation verification, operational verification, and PQ support activities.
- Coordinate with construction, automation, validation, QA, and vendors to resolve issues.
- Enforce LOTO procedures and site safety compliance.
- Manage punch lists, deviations, and commissioning documentation.
- Support DeltaV-based systems where applicable (FAT/SAT, integration, troubleshooting).
Required Experience
- 5–10 years commissioning/startup experience in pharma or large-scale regulated capital projects.
- Strong background in utility systems startup and handover.
- Proven experience leading field execution and commissioning teams.
- Deep understanding of IV/OV/OQ execution and documentation.
- Full-time onsite availability in Indianapolis.