Process Engineer - Clean Room Manufacturing

Our global medical device client is currently seeking a Process Engineer to actively troubleshoot, develop and refine production process equipment and systems. The successful individual will support the department in maintaining a validated process, working with process improvement projects, problem solving, and maintain the support of key site processes.

KEY RESPONSIBILITIES

- Monitoring process key performance indicators (KPI's), identifying trends, implementing corrective actions and process improvements in a GMP environment.
- Ensuring all Engineering systems operate as per validated process and ensuring all routine validation is completed on time.
- Troubleshooting and giving continuous technical support to specific processes in conjunction with the maintenance, Business Unit, and Quality Departments
- Carry out process capability studies as required
- On-going process and equipment development in terms of Safety, Quality, and Productivity

QUALIFICATIONS/REQUIREMENTS

- Engineering degree/diploma in manufacturing, process, mechanical or electrical engineering or related discipline.
- Extensive engineering experience in development, process, maintenance, or project work in pharmaceutical or process industry within an FDA approved environment covering the following areas: Sterile product preparation and Batch Filling
- Good knowledge of and experience with SPC, Technical Documentation, Engineering Standards, and Guidelines. Validation Lifecycle and Computer Software validation experience.
- Excellent written and oral communications skills and the ability to deal with a variety of people on a wide range of tasks.
- Must be good record keeper and results analyser

If this long term opportunity, paying competitive rates, working with cutting edge technology is of interest, then please contact me immediately.