Senior Process Development Engineer
3 weeks ago
About the Role:
We are seeking a highly skilled Senior Process Development Engineer to join our engineering team at our facility in Cambridgeshire. As a key member of our team, you will be responsible for contributing to project management and achieving project milestones.
Key Responsibilities:
- Implement pharmaceutical and regulatory requirements for manufacturing processes and equipment.
- Develop and validate manufacturing processes in support of business development and IP generation via proprietary processes or techniques.
- 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 whilst 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.
Requirements:
- Engineering experience in a GMP environment.
- Degree qualified, preferably in Chemical Engineering or related subjects.
- Specification, selection, and installation of CAPEX equipment.
- Ability to write technical documents including knowledge of regulations and best practices within pharmaceutical manufacturing.
- Validation activities including specification writing, qualification testing, and reporting.
- Experience working under the GMP and ISO13485 quality systems.
- Experience in risk assessments and risk management.
About Us:
Adepto Technical Recruitment Ltd is a leading recruitment agency specialising in technical and engineering roles. We are committed to providing exceptional service and support to our clients and candidates.
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