|Job Title:||Automation Process Engineer|
|Contact Name:||Heather McGowan|
Our exclusive MedTech client in Galway city is seeking to hire an Automation Process Engineer. This role offers an excellent opportunity for an experienced Automation Process Engineer to work in a challenging and dynamic environment. You will support customers at all levels across the business in the MedTech market so experience in this sector would be a distinct advantage.
You will be part of the site engineering team working on technical solutions for new / upgrading projects on existing systems and equipment. You will report to the Engineering Manager.
- B.Sc. in Mechanical, Industrial or other Engineering Science and demonstrated 5+ years of Validation experience.
- Competent knowledge of the medical device industry and of 21 CFR, (820, 11), ISO13485
- Good knowledge of ISO13485 standard
- Excellent communicator
- Excellent report writing, analytical and problem solving skills as well as understanding of root cause analysis methods.
- Skilled user of engineering tools and software packages to design and automate manufacturing processes i.e. AutoCAD, SOLIDWORKS.
- Knowledge of Validation protocols, (FAT, SAT, CAPA, IQ/OQ/PQ, FMEA, SOP’s, Control Plans
- Familiar with control procedures, such as the Change Notification and Deviation process, and Engineering Specifications.
- Ability to liaise directly with clients, maintain and develop the client relationship
- Microsoft Office Suite and Project; Statistical Process Control skills
Job Requirements and Responsibilities
- Developing project charters, plans, schedules and implementing cost reduction plans, waste reduction, increased throughput and general operational improvement through the use of Six Sigma statistical methods.
- Design of equipment and ensuring it is up to current regulations and design standards.
- Reporting on new or modified equipment capabilities, qualifications (IQ/OQ/PQ), and validations.
- Support validation assessment and validation execution for Clean, Automated and Packaging processes.
- Assist in SAT/FAT as required.
- Troubleshoot daily production and process problems, communicate any issues with plant management team, supervisors and operators regarding run problems, investigates root causes, recommends and implements CAs.
- Establishing process methods which meet performance and quality requirements.