Process Expert (m/f/d)
Core
Technical expert for Visual Inspection operations ensuring reliable, compliant, and efficient Drug Product manufacturing.
Role type
Process Expert (Manufacturing)
Builds
Drug Product manufacturing processes and operational excellence
Domain
Pharmaceutical manufacturing
Required skills
Process knowledge, deviation management, corrective actions, continuous improvement, batch record creation, regulatory inspection support, qualification and validation
Preferred skills
Manufacturing environment experience, pharmaceutical or biotechnology industry experience, exposure to deviation management, qualification activities, or process improvement initiatives
Technologies
None stated
Responsibilities
Act as process expert for Drug Product manufacturing within Visual Inspection operations; Build deep process knowledge and provide technical support to ensure safe, compliant, and reliable manufacturing execution; Independently manage multiple operational topics, priorities, and deadlines in a dynamic production environment; Lead investigations, define corrective actions, and implement sustainable solutions to prevent recurrence of deviations; Drive continuous improvement initiatives to enhance process performance, product quality, and operational efficiency; Create and maintain master batch records and manufacturing documentation in compliance with quality requirements; Support health authority, regulatory, and customer inspections by providing process expertise and ensuring inspection readiness; Support qualification, validation, and implementation activities for processes, equipment, and documentation changes
Seniority
Mid-level, hands-on IC
