Senior Process Development Engineer
2 weeks ago
Senior Process Development Engineer - Pharmaceutical - Cambridgeshire
Overview:
Our client, a leading pharmaceutical development and manufacturing organisation, is seeking a Senior Process Development Engineer to join their engineering group on a permanent basis at their facility in Cambridgeshire. The successful candidate will contribute to project management and achievement of project milestones, implement pharmaceutical and regulatory requirements for manufacturing processes and equipment, and develop and validate manufacturing processes in support of business development and IP generation.
Responsibilities:
- Contribute to project management and achievement of project milestones.
- Implement pharmaceutical and regulatory requirements for manufacturing processes and equipment.
- Develop and validate manufacturing processes in support of business development and IP generation.
- Lead technical projects, including generation of specifications, conducting supplier selection, managing supplier relationships during the build phase, and performing commissioning activities.
- Support commissioning and qualification activities of manufacturing equipment, facilities, and utilities, including authoring and execution of validation protocols.
- Work with process development and manufacturing functions to translate developed formulations/processes to final clinical products.
- Perform design feasibility for customer devices and provide engineering solutions to enable technical transfer into the facility while ensuring future scalability.
- Provide technical support to the Device Development team to ensure device platforms are compatible with fill-finish systems.
- Keep up to date with market trends and seek better engineering solutions to ensure the company has a competitive edge with standardised yet adaptable equipment/systems for process development and manufacturing.
- Conduct risk analysis of processes, including prioritisation and implementation of mitigations.
- Work collaboratively with Business Development and other technical colleagues, providing support related to proposal/project development and direct customer engagement.
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