Description
We are currently looking for a new Manufacturing Technology Engineer to join our client's Manufacturing Technology Department based in Loughborough.
The successful applicant will be working as part of a technical team focused on product understanding and improvements. The product ownership role includes writing and managing technical documentation, reviewing product performance and ownership of process validation for Pharmaceutical products. The role will involve interaction with internal manufacturing, logistics and technical colleagues and possible interaction with customers/suppliers.
Responsibilities include:
- Provide ongoing technical support for a specific product family, including writing batch manufacturing records, writing manufacturing production recipes and relevant documentation updates.
- Leadership of annual Product Quality Reviews including analysis product performance data, presentation of information and completion of improvements identified.
- Involvement in the broader technical activities of the MT Team to ensure technical development and improvement of manufacturing processes.
- Leadership of root cause investigations and reviewing potential quality impact for product family.
- Further develop product and process understanding for the value stream manufacturing processes.
- Prepare and execute process validation documents
Skills required:
- Data analysis and subsequent technical review and interpretation of statistics is very desirable.
- Experience in GMP within a contract manufacturing environment of Medical Devices or Pharmaceuticals is very desirable.
- Lean Six Sigma Green Belt trained is desirable.
- Process validation experience is desirable.
- Introduction of new equipment and processes.
- Knowledge of Medical Device and Drug Product Quality Systems and GMPs for EU, US and ROW: ISO13485, Orange Guide is desirable.
Full details available upon application.