Engineer - F&E Environmental & Contamination Control
Core
Technical deviation owner responsible for investigating and resolving equipment, utility, automation, facility, and project-related quality events in a biomanufacturing environment.
Role type
Senior IC engineering deviation owner (pharmaceutical manufacturing)
Builds
Inspection-ready quality documentation and validated system reliability
Domain
Pharmaceutical manufacturing / Biotechnology / Quality Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, technical writing, deviation investigation, CAPA development, data analysis, cross-functional collaboration, regulatory compliance, equipment troubleshooting, utility system management, automation system oversight, change control management
Preferred skills
AI-enabled tools application, digital analytics, influence without authority, commissioning and qualification expertise, regulated manufacturing environment experience
Technologies
DeltaV, BAS, PI
Responsibilities
Drive deviation investigations from initiation through closure, conduct field assessments and equipment walkdowns, lead structured root cause analysis sessions, develop corrective and preventive actions, serve as SME during regulatory inspections, analyze deviation trends for continuous improvement
Seniority
Senior, hands-on IC