
Technical Process Expert
19 hours ago
We are currently recruiting for an exciting position in a leading pharmaceutical organization.
The Technical Process Expert delivers technical support to the Drug Substance Business, leading investigations and supporting projects.
- Ensure compliance of Global Policies, Procedures and Guidelines.
- Implement current Good manufacturing Practices (cGMP) in daily activities.
- Design/Author/Review/Approve/Execute qualification documentation.
- Lead experimental design, execution, data analysis and interpretation.
Key Responsibilities:
- Support batch documentation, regulatory and technical documentation.
- Interpret trends in commercial process monitoring.
- Support development and PPQ batches.
- Lead multidisciplinary teams for process improvement and troubleshooting.
- Participate in audits and inspections.
Requirements:
Bachelor degree in a scientific or engineering field,
Minimum 5 years of relevant post-degree work experience in GMP Manufacturing,
Prior experience in drug substance process development and process characterisation studies,
Knowledge of process monitoring systems, automation systems (Delta V), operational intelligence & data systems (Pi System) within a GMP manufacturing environment,
Specialist in upstream/downstream processing and process control strategies.
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