Clean Utilities SME Engineer
Core
Technical authority for GMP manufacturing utility systems including Purified Water, Water for Injection, Clean Steam, and cleanroom HVAC.
Role type
Senior Clean Utilities Specialist/SME
Builds
Critical utility infrastructure supporting pharmaceutical manufacturing
Domain
Biopharma / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> infrastructure
Required skills
GMP Compliance, Utility Systems Design, Root Cause Analysis, CAPA development, Qualification Protocols (IQ/OQ/PQ), Vendor Management, Project Management, Preventative and Corrective Maintenance, Trend Analysis, Failure Mode Analysis
Preferred skills
Emerging digital/PAT technologies, Energy Engineering
Technologies
CMMS, GMP standards, Pharmacopoeial standards
Responsibilities
Lead technical design reviews for utility system installations and modifications; Serve as escalation point for complex technical failures and lead root cause investigations; Act as key SME during regulatory inspections and audits; Identify and implement reliability and efficiency improvement opportunities; Evaluate and select equipment vendors and service providers; Provide technical mentorship to maintenance technicians and junior engineers
Seniority
Senior, hands-on IC
