Equipment Owner

Techtrueup • Lebanon, IN

3d • Onsite

About The Position

The equipment owners manages the technical lifecycle of critical process equipment ensuring it is designed, fabricated, delivered, started-up, commissioned, qualified, and validated in accordance with site expectations and the master schedule.

Requirements

• Experience: 8+ years in life science or heavy manufacturing, with a focus on specific process areas like bioprocessing (Upstream/Downstream) or aseptic filling.
• Technical Proficiency: Deep understanding of equipment lifecycle from procurement to operational readiness while ensuring all data integrity (ALCOA+) and 21 CFR Part 11 requirements are met.
• Autonomy: Proven ability to drive work collaboratively in high pressure environments and troubleshoot while maintaining schedule and budgets.

Responsibilities

• Design & Specification: Collaborate with the AMEP and design teams to define User Requirement Specifications (URS) and detailed engineering specs. Ensure the design meets facility constraints and process needs.
• Vendor Management: Lead technical reviews of vendor bids and submittals. Perform shop inspections and participate in Factory Acceptance Testing (FAT) to verify the equipment is built to spec before it arrives on-site.
• Receipt Verification: Ensure equipment delivered matches the purchase order (PO) specifications, quantity, and quality standards before being accepted.
• Installation & Integration: Oversee the physical installation on the greenfield/brownfield site, coordinating with multiple trades to ensure proper utility hook-ups and spatial alignment.
• System start-up and SAT: Coordinate system start-up and site acceptance testing with site and trades, as applicable.
• CQV Leadership: Coordinate the CQV document development and execution phases with associated teams. Manage deviations and technical issues during site testing and resolve issues.
• Operational Transition: Facilitate the "turnover" from construction to operations. This includes training end-users, finalizing maintenance SOPs, and ensuring the equipment is "operations-ready".

What This Job Offers

• Education Level: No Education Listed