Description
Quality Manufacturing Engineer within Aseptic Operations required to join a medical device company located in the UK. Activities include support for and improvements to traditional and advanced pharmaceutical manufacturing processes and technologies such as compounding, mixing, aseptic assembly and filling, mechanical component fabrication, high-level automation, controlled release technologies and packaging. Production activities include clinical as well as commercial scale processes.Role and Responsibilities:
* Lead investigations of and resolutions to specific manufacturing or production quality and throughput issues with contract manufacturers, equipment, and component and/or raw material suppliers
* Provide aseptic technical expertise with regard to pharmaceutical manufacturing equipment, processes and components.
* Through careful and scientific analysis, develop optimization plans for the aseptic manufacturing equipment, processes and operating procedures
* Support improvements in process robustness, efficiency, yield, and manufacturing costs, working in close collaboration with the relevant CMP and component supplier representatives and internal functions.
* Work with the CMO to ensure a robust and reproducible manufacturing process, including the development and supervision of effective continuous improvement processes.
* Draft, review and approve master manufacturing templates and documentation including Standard Operating Procedures, Master Batch Manufacturing Records, Training Records and Specifications.
* Recommend enhancements to systems and processes within the pharmaceutical manufacturing operation, associated with proposed product changes
Required Skills and experience:
* Bachelor`s Degree in Mechanical, Chemical or Electrical Engineering
* 8-10 years` experience in an aseptic pharmaceutical environment utilizing highly automated manufacturing processes
* Significant experience working with third party vendors, contractors and contract manufacturers in a role requiring relationship management. Must have experience influencing partner organizations to achieve positive outcomes without reporting or significant economic leverage
* The candidate must have experience with validation of automated equipment, and familiarity with cGMP and Regulatory aspects of aseptic filling processes.
* Training/Certification in lean manufacturing and in leading and closing out investigations, deviations and CAPA activities
* Project management skills and specific experience managing outside contractors/suppliers is also required.
* Strong electrical & mechanical troubleshooting skills and knowledge.
* Language skills in German would be a bonus.
If this is you please apply today.