Engineering, Specialist, Technical Operations Deviation Management
Core
Provide on-site engineering technical support for Deviation Management, including Supplier, Incoming Materials, and Environmental Monitoring investigations, to ensure manufacturing compliance and operational continuity.
Role type
Specialist Technical Operations Engineer (Deviation Management)
Builds
Manufacturing operations compliance and continuous improvement processes
Domain
Pharmaceutical manufacturing (Biologics/Vaccines)
Deliverable
dashboards & analysis
Required skills
Deviation Management, Root Cause Analysis, Corrective Action Management, Change Control, GMP, Technical Writing, Project Management, Data Analysis, Equipment Troubleshooting, Regulatory Compliance
Preferred skills
Biologics manufacturing experience, Vaccine manufacturing experience, Bulk sterile manufacturing experience, Lean Manufacturing, Process Optimization
Responsibilities
Author incident and investigation reports for deviations, Coordinate and complete CAPAs, Author and review Incident Trend Reports, Support deviation reduction efforts, Lead or participate in Quality Risk Assessments, Support regulatory inspections/audits, Manage project timelines for compliance and customer due dates
Seniority
Mid-level, hands-on IC
