Stop the press!!! I want to speak to candidate with Manufacturing Execution System Quality experience as I have an exciting opportunity to discuss with you.
My client a leading Medical Device Manufacturer based in Oxford is looking to appoint an experienced MES Quality Engineer who will be involved in the MES introduction across the site, leading the design, validation and implementation of a critical Project.
MES (Manufacturing Execution System) is a software application that is deployed to support manufacturing’s drive for Compliance, Productivity and Manufacturing Intelligence.
MES software provides control over each part of a production process. From incoming raw materials and inventory tracking, to manufacturing steps, to finished goods shipping, MES tracks every step and stores all data associated with a given product. MES controls and maintains the data required to validate each process step, so its advantages apply across all process industries.
As this business critical MES Quality Engineer you will be responsible for the following duties.
- Support the Engineering / Operations / R&D / Technical Services areas in designing, creating and writing MES Recipes, worksheets
- Troubleshoot and providing solutions for MES problems in recipe execution and authoring.
- Generate and execute system and test documentation in a GMP compliant manner.
- Work closely with IT regarding upgrades, patching, hardware support, security and system access.
To be successful as the MES Quality Engineer, you will bring previous experience of design and change control, validation processes, project and risk management, ideally gained within the Medical Device or Pharmaceutical industry or other highly regulated industry.
You will also offer knowledge of cGMP, ISO13485, and 21 CFR 820 or have worked within another highly regulated industry such as Automotive, Aerospace, Food, Beverage Cosmetics.
The ideal candidate will be a proactive individual who takes initiative and is able to work independently as well as part of a high performing cross functional team within a regulated, quality-driven environment.
As a minimum you will be qualified to secondary level education, however further education/degree level qualifications in a Science or Engineering discipline are advantageous.
Preference will be given to those with experience in the below or proven experiences of working with MES systems.
- Understanding of programming (Windows based programs) and Capability to adapt to programs.
- Ability to read existing codes (Scripting, PTL, C#, SQL).
- Strong technical problem-solving and analytical skills.
- Analyse data requirements with relevant business teams to propose process improvements which may influence architectural implementations.
- Knowledge and experience of working with large transactional datasets.
- Experience with data technologies to enable data analytics from a production environment.