Job Title : Equipment Engineer
Location: Illinois, United States
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.