Specialist Manufacturing – Contamination Control Process Owner
Core
Own operational processes and procedures supporting contamination controls, including facility control, environmental control, aseptic behavior, bioburden/endotoxin controls, and equipment cleaning/sanitization within a biotechnology manufacturing plant.
Role type
Specialist Manufacturing – Contamination Control Process Owner
Builds
Drug substance manufacturing processes at the FleX Batch facility
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Contamination Control Strategy implementation, Quality Risk Assessments, Process and Procedure Ownership (SOPs), Microbial Awareness Training, Inspection Readiness, Regulatory Inspection responses, Deviation Investigations/CAPAs/Change Controls, Trend analysis
Preferred skills
Upstream/Downstream Manufacturing expertise, Aseptic operations knowledge, GMP manufacturing experience, GMP documentation authoring, Change control support, Risk assessment participation, Technical writing
Technologies
Industry 4.0 capabilities, Disposable technologies, Stainless-steel equipment
Responsibilities
Implement Contamination Control Strategy (CCS) requirements, Lead or contribute to local process assessments, Own operational processes and SOPs for gowning/cleaning/material flow, Provide microbial awareness training, Maintain inspection readiness and records, Support root cause analyses and CAPAs, Track process issues and effectiveness
Seniority
Specialist, hands-on IC