We are currently recruiting for an exciting opportunity with a leading medical device organization. This is an excellent position for anyone who is looking to join a multinational that excels in their field.
Job Description
1. Provide engineering support in developing new or improving existing equipment and/or process related activities.
2. Define or assist in defining process equipment requirements and specifications based on process requirements, safety requirements and customer needs.
3. Perform project management tasks for small to medium scale projects involving either new or existing equipment.
4. Assist in determining the budget to support requirements. Evaluate or assist in evaluating technology necessary to support requirements. Propose options to Management/Stakeholders.
5. Provide technical support for projects. Support and/or develop and execute equipment or process related validations in accordance with IML requirements, processes and procedures.
6. Assist in negotiation with equipment suppliers. Utilise necessary project tools to manage projects successfully.
7. Develop the necessary equipment, process and product knowledge to be recognised as a local expert. Measure/evaluate equipment efficiencies, downtime and assist in the development of maintenance requirements.
8. Propose and implement improvement projects that improve compliance, improve efficiencies, yields or throughputs.
9. Define root cause and implement solutions to equipment and process related non-conformances utilising the NCMR and CAPA processes.
10. Knowledge of equipment and process validation and documentation procedures and processes.
Required Skills and Qualifications
* Engineering Degree or equivalent experience.
* Experience in a technical position in a highly regulated industry.
* Experience in equipment and process validation activities.
* Process development experience. Equipment conceptual skills. Experience of bespoke capital equipment.