Pharma Equipment Package Lead — FAT & Startup

QCS Staffing Ltd; Ohio; On-site; USD 120,000 - 180,000; Full time

Job summary

QCS Staffing Ltd. seeks an Equipment Package Lead for a 12‑month life sciences project in Ohio. The role focuses on leading FAT activities, interfacing with equipment vendors, and coordinating with process, automation, facilities, and quality teams to advance this world‑class facility build.

The candidate will review design docs (P&IDs, URS/FRS, datasheets) and support IQ/OQ/PQ, SAT, commissioning, startup, and qualification efforts, ensuring cGMP compliance throughout the lifecycle.

Qualifications

• Bachelor's degree in Engineering required.
• Extensive pharma/biotech engineering experience.
• Experience with process and utility equipment packages from design to startup.
• Experience leading FATs and coordinating with vendors.
• Knowledge of cGMP and FDA regulations.

Responsibilities

• Review and approve equipment design documentation including P&IDs, URS/FRS, datasheets, and GA drawings.
• Serve as the primary technical interface with equipment vendors.
• Lead and execute FAT activities, including protocol review, punch list management, and report approvals.
• Support SAT, commissioning, startup, and qualification activities (IQ/OQ/PQ).
• Coordinate with process, automation, facilities, piping, validation, and quality teams.

Skills

FAT coordination

Vendor interface

IQ/OQ/PQ coordination

GxP knowledge

FDA regulations

Education

Bachelor's Degree in Engineering

Job description

QCS Staffing Ltd. seeks an Equipment Package Lead for a 12‑month life sciences project in Ohio. The role focuses on leading FAT activities, interfacing with equipment vendors, and coordinating with process, automation, facilities, and quality teams to advance this world‑class facility build.

The candidate will review design docs (P&IDs, URS/FRS, datasheets) and support IQ/OQ/PQ, SAT, commissioning, startup, and qualification efforts, ensuring cGMP compliance throughout the lifecycle.