Equipment Package Lead — Pharma Plant Startup

QCS Staffing Ltd; Ohio; Vor Ort; USD 95.000 - 130.000; Vollzeit

Zusammenfassung

QCS Staffing Ltd is seeking an Equipment Package Lead for a US Ohio-based, 12-month contract in the life sciences sector. You will support a new-build facility and act as the primary technical interface with equipment vendors, leading FAT activities and coordinating with multi-disciplinary teams.

You should have a Bachelor's degree in Engineering and proven experience with process and utility equipment packages from design through startup, along with strong knowledge of cGMP and FDA regulations.

Qualifikationen

• Bachelor's Degree in Engineering (Mechanical, Chemical, Electrical, or related)
• Engineering experience in pharmaceutical/regulated manufacturing.
• Experience with process and utility equipment packages from design to startup.
• Experience leading FATs and coordinating with equipment vendors.
• Knowledge of cGMP and FDA regulations in pharmaceutical equipment lifecycle.

Aufgaben

• Review and approve equipment design docs including P&IDs, URS/FRS, datasheets, and GA drawings.
• Interface with equipment vendors as the primary technical contact.
• Lead FAT activities, 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.

Kenntnisse

FAT coordination

Vendor management

cGMP knowledge

FDA regulations

Equipment lifecycle management

Ausbildung

Bachelor's degree in Engineering

Jobbeschreibung

Equipment Package Lead – US, Ohio – Initial 12-Month Contract – Life Sciences

Be part of a next-generation pharmaceutical project that’s transforming how medicines are made.

Equipment Package Lead – US, Ohio – Initial 12-Month Contract – Life Sciences

Be part of a next-generation pharmaceutical project that’s transforming how medicines are made.

We’re supporting a major new-build facility in Ohio, a multi-billion-dollar investment designed to push the boundaries of science and engineering. We’re looking for an Equipment Package Lead to support this project and help deliver this world-class program.

What You’ll Deliver

• 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.
  
  

What you’ll need:

• Bachelor's Degree in Engineering (Mechanical, Chemical, Electrical, or related discipline).
• Extensive engineering experience within pharmaceutical, biotech, or regulated manufacturing environments.
• Direct experience with process and utility equipment packages from design through startup.
• Experience leading FATs and coordinating with equipment vendors.
• Strong knowledge of cGMP, FDA regulations, and pharmaceutical equipment lifecycle management.
  
  

Don’t miss your chance to be part of something extraordinary, apply now and let’s talk!