Engineer - Engineering
Core
Manage equipment lifecycle, support utility systems (HVAC, process utilities, bio-containment), and ensure facility compliance with FDA GMP requirements in a biopharmaceutical manufacturing environment.
Role type
Facilities and Equipment Engineer (cGMP)
Builds
Manufacturing equipment, utility systems, and compliant facility infrastructure
Domain
Biopharmaceutical manufacturing / Life Sciences
Deliverable
infrastructure
Required skills
Equipment lifecycle management, HVAC and process utility systems knowledge, FDA GMP compliance, SOP authoring, change control and deviation investigation, capital expenditure (CapEx) management, cross-functional project leadership
Preferred skills
Cross-department facility improvement project leadership
Technologies
CMMS, URS (User Requirement Specifications), Change Management systems
Responsibilities
Support utility systems facility including HVAC, process utilities, and bio-containment systems; Manage equipment lifecycle from onboarding to decommissioning; Partner with commissioning/validation teams to implement FDA GMP compliance; Draft SOPs for building operation and maintenance; Guide specification and selection of manufacturing/utility equipment; Perform hands-on troubleshooting and support facility staff
Seniority
Mid-level, hands-on IC
