MSAT Bioprocess Engineer

Key Roles/Responsibilities:
- Prepare GMP batch records for use in GMP manufacturing processes.
- Review, approve, and issue manufacturing documentation.
- Determine scale-up criteria from development to manufacturing scale.
- Generate process mass balances and flow diagrams.
- Identify, design and define large scale manufacturing equipment.
- Define materials for use in a GMP manufacturing environment
- Generate quality documentation for raw materials and equipment.
- Work within the Piramal quality system to initiate, manage and evaluate requests for change.
- Perform investigations, close CAPA’s and deviations.
- Project manage all aspects of the introduction of processes to manufacturing.
- Perform risk assessments in alignment with ICH 9Q.
- Evaluate process materials for suitability for use in manufacturing.
Competencies:
- Good time organisation skills
- Strong team working ability
- Good communication skills
- High level of attention to detail
- Good problem solving skills
- Good decision making skills