Main characteristics
- Location
- Stirling and Falkirk
- Company
- The Gxp Recruitment Company
- Employment type
- Permanent
- Category
- Medical / Pharmaceutical / Scientific
Job summary
GxP Recruitment invites applications on behalf of our biopharmaceutical client in Grangemouth where an excellent new opportunity now exists for an NPI Bioprocess Engineer to join their site on a permanent basis.Job Purpose:
Responsible for siting both new processes and repeat campaigns to manufacturing. Generate all required process and technical documentation for implementation of processes to manufacturing.
Key duties include:
* Prepare GMP batch records for use in 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 quality system to initiate, manage and evaluate requests for change. Perform investigations, close CAPAs 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.
The ideal candidate:
* A degree in a science or engineering discipline is preferred
Essential experience:
* Proven GMP Biologics manufacturing or process development experience and technical knowledge and ability
* Strong leadership skills and organisational skills to influence and gain support from key departmental areas that collaborate to deliver technical transfer projects
* Project management of technical teams and projects
* Process scale up, transfer and manufacturing support
* A proven ability to meet project costs and deadlines is essential
* Ability to communicate with vast cross sections of people is essential
* Evaluation of materials for process suitability
* Writing GMP batch records
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