Process Expert

Key Responsibilities

• Provide front line support to manufacturing
• Maintain master manufacturing documents
• Ensure critical parameters are within written instructions
• Manage process changes through change control procedures
• Create production SOPs and Master Batch Records
• Act as Subject Matter Expert for product and process knowledge
• Collect data for ongoing process verification
• Perform first line evaluation of product and process related issues
• Support product steward for technical changes and root-cause analysis
• Maintain processes at inspection readiness level
• Support process optimization and new technology introduction
• Review validation protocols and reports
• Support execution of process validations and improvement projects
• Create master manufacturing documents
• Provide input during process transfer
• Ensure technical batches generate sufficient process knowledge
• Support technology trainings for production operators

Requirements

Education

BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree

Experience

Minimum 3 years

Required Skills

• Process understanding (Pharma, GMP, Regulatory aspects)
• Front line expert support
• Continuous improvement
• Compliance with cGMPs, SOPs, and guidelines
• Document management
• Change control
• Data analysis
• Root cause analysis
• Quality risk assessment
• Process optimization
• Validation
• Technology transfer