Senior Process Development Engineer
2 weeks ago
About the Role:
We are seeking a highly skilled Senior Process Development Engineer to join our engineering group on a permanent basis at our facility in Cambridgeshire. As a key member of our team, you will contribute to the development and implementation of pharmaceutical manufacturing processes and equipment, ensuring compliance with regulatory requirements.
Key Responsibilities:
- Contribute to project management and achievement of project milestones, working closely with cross-functional teams to deliver high-quality results.
- Implement pharmaceutical and regulatory requirements for manufacturing processes and equipment, ensuring compliance with GMP and ISO13485 quality systems.
- Develop and validate manufacturing processes in support of business development and IP generation, leveraging proprietary processes or techniques.
- Lead technical projects, including specification writing, supplier selection, and commissioning activities, ensuring seamless integration with manufacturing functions.
- Collaborate with process development and manufacturing functions to translate developed formulations/processes to final clinical products, ensuring scalability and adaptability.
- Provide technical support to the Device Development team, ensuring device platforms are compatible with fill-finish systems, and contribute to proposal/project development and direct customer engagement.
Requirements:
- Engineering experience in a GMP environment, with a degree in Chemical Engineering or related subjects.
- Proven track record of specification, selection, and installation of CAPEX equipment, with experience in risk assessments and risk management.
- Ability to write technical documents, including knowledge of regulations and best practices within pharmaceutical manufacturing, and validation activities.
- Experience working under the GMP and ISO13485 quality systems, with a strong understanding of pharmaceutical manufacturing processes and equipment.
About Us:
Adepto Technical Recruitment Ltd is a leading recruitment agency specializing in technical and engineering roles. We are committed to providing exceptional service and support to our clients and candidates, and we are excited to offer this opportunity to a highly skilled and motivated individual.
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