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Equipment Engineer

i-Pharm GxP

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. #J-18808-Ljbffr i-Pharm GxP

Vacancy posted 1 day ago
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