Senior Process Development Engineer - Pharmaceutical - Cambridgeshire - Permanent
Overview:
Our client is a leading pharmaceutical development and manufacturing organisation at the cutting edge of the industry. They are seeking a Senior Process Development Engineer to join their engineering group on a permanent basis at their facility in Cambridgeshire. The successful candidate will:
1. Provide technical leadership for the acquisition and qualification of capital expenditure equipment and systems.
2. Contribute to project management and achievement of project milestones.
3. Implement pharmaceutical and regulatory requirements for manufacturing processes and equipment.
4. Develop and validate manufacturing processes in support of business development and IP generation via proprietary processes or techniques.
5. Support Manufacturing teams with technical troubleshooting of Fill Finish Processes.
Experience:
1. Engineering experience in a GMP environment.
2. Degree qualified, preferably in Chemical Engineering or related subjects.
3. Specification, selection, and installation of CAPEX equipment.
4. Ability to write technical documents including knowledge of regulations and best practices within pharmaceutical manufacturing.
5. Validation activities including specification writing, qualification testing, and reporting.
6. Knowledge and/or experience of drug product handling & filling operations for drug delivery devices.
7. Knowledge of manufacturing process design, scaling, and characterisation.
8. Knowledge of QbD, DoE, and statistical process control methodologies.
9. Experience working under the GMP and ISO13485 quality systems.
10. Experience in risk assessments and risk management.
11. Aseptic and sterile experience.
Responsibilities:
1. Lead technical projects including generation of specifications, conducting supplier selection, managing supplier relationships during the build phase, and performing commissioning activities.
2. Support commissioning and qualification activities of manufacturing equipment, facilities, and utilities including authoring and execution of validation protocols.
3. Work with process development and manufacturing functions to translate developed formulations/processes to final clinical products.
4. Perform design feasibility for customer devices and provide engineering solutions to enable technical transfer into the facility whilst ensuring future scalability.
5. Provide technical support to the Device Development team to ensure device platforms are compatible with fill-finish systems.
6. 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.
7. Conduct risk analysis of processes including prioritisation and implementation of mitigations.
8. Create resource plans and costings for customer proposals.
9. Generate and communicate reports and presentations.
10. Work collaboratively with Business Development and other technical colleagues, providing support related to proposal/project development and direct customer engagement.
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