Equipment Engineer

i-Pharm GxP; Illinois; On-site; USD 80,000 - 110,000; Full time

Job summary

i-Pharm GxP is seeking experienced Equipment Engineers for a 12-month contract to take full lifecycle ownership of critical Fill Finish equipment in a large-scale GMP manufacturing expansion in Illinois.

This hands-on role requires strong end-to-end experience in GMP healthcare environments, particularly with aseptic processes, and involves responsibilities from concept through operational handover and qualification.

Qualifications

• 5-7+ years in GMP pharmaceutical or biotech manufacturing.
• Proven experience in aseptic Fill Finish environments.
• Strong understanding of GMP lifecycle management.

Responsibilities

• Own equipment lifecycle activities from concept and procurement through to operational handover.
• Develop URS, Purchase Specifications, and Design Specifications.
• Lead design reviews and oversee installation, commissioning, and startup.

Skills

GMP pharmaceutical manufacturing

Aseptic Fill Finish environments

End-to-end equipment lifecycle management

Troubleshooting

Vendor management

Job description

Contract: 12-month Contract (4-5 year scope, likely renewals)

Onsite Requirement: Full-Time, 5x days a week onsite

Overview

We are supporting a large-scale GMP manufacturing expansion programme and are seeking experienced Equipment Engineers to take full lifecycle ownership of critical Fill Finish equipment within a highly regulated pharmaceutical environment.

This is a hands‑on role covering the complete equipment lifecycle - from concept, design and procurement through commissioning, qualification, startup and operational handover. You will work closely with Engineering, CQV, Automation, Manufacturing, Quality, Validation and Vendors throughout.

Key Responsibilities

• Own equipment lifecycle activities from concept and procurement through to operational handover.
• Develop URS, Purchase Specifications and Design Specifications; participate in RFQ processes and vendor selection.
• Lead and participate in design reviews, P&ID reviews, FAT, SAT and vendor oversight activities.
• Oversee installation, commissioning, startup, cycle development and operational readiness.
• Support CQV Leads with qualification strategy, risk‑based approaches and IQ/OQ/PQ execution.
• Support Validation Leads with Media Fills, Cleaning Validation, PPQ and protocol development.
• Support Automation and Control System requirements including ISA-88, alarm categorisation and interlock assessments.
• Develop SOPs, training materials and operational documentation; deliver handover to Manufacturing and Operations.

Required Experience

• 5–7+ years in GMP pharmaceutical or biotech manufacturing, with proven experience in aseptic Fill Finish environments.
• Strong end‑to‑end experience across URS development, design reviews, FAT/SAT, commissioning, qualification and validation.
• Solid understanding of GMP lifecycle management, CQV principles, risk‑based qualification and current Annex 1 requirements.
• Strong troubleshooting capability, vendor management experience and a genuine equipment ownership mindset.

Preferred Experience

• Hands‑on experience with one or more: Filling Equipment, Lyophilizers, Isolators, Autoclaves, Washers, Inspection Equipment, CCIT, Stopper Processing Equipment, Tanks and Process Piping.
• Experience supporting automation integration, recipe setup and operational configuration.
• Comfortable taking ownership in a fast‑paced, large‑scale capital project environment.