Sr. 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 deviation records, root cause analyses, and corrective/preventive actions for validated systems
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, data integrity management, cross-functional collaboration, regulatory compliance knowledge, equipment troubleshooting, utility system management, automation system oversight, CAPA development, trend analysis
Preferred skills
AI-enabled tools application, digital analytics, change control management, influence without authority, commissioning and qualification expertise
Technologies
DeltaV, BAS, PI
Responsibilities
Lead structured Root Cause Analysis (RCA) sessions involving cross-functional stakeholders; Develop technically robust corrective and preventive actions aligned with investigation outcomes; Conduct field assessments, equipment walkdowns, and system reviews to gather factual evidence; Serve as a Subject Matter Expert (SME) during regulatory inspections and internal audits; Analyze deviation trends associated with equipment reliability and utility performance; Develop investigation narratives that clearly communicate event chronology and causal analysis
Seniority
Senior, hands-on IC