Our customer, a leading provider of new and innovative medical device products based in Galway require an Equipment Validation Engineer. Reporting to the Stericycle GxP Project Supervisor and working as part of the on-site customer engineering team, the Equipment Validation Engineer will be responsible for preparation of the equipment documentation.
- Degree Qualified in electrical or electro/mechanical engineering or related field
- Experienced in equipment development and validation
- 5 years experience min. of working in a regulated manufacturing engineering environment on medium to large scale projects
- Comfortable taking direction but pro-active fro the most part
- Able to work in team environment
- Strong written and verbal communication skills
The Ideal Candidate
Roles & reponsibilities
- Execution of test protocols
- Prepare repoprts of executed protocols for review by QA - work closely with QA
- Co-ordinate qualification document review and approval
- Understanding of process performance and process capability
- Participate in cross functional teams as required
Develop validation documentation as required - at a minimum:
- User Requirements Specification
- Risk Assessments
- Identify a modular testing strategy based on vendor equipment specification (ES) and defined in a test plan (EDST)
- Requirements Traceability Matrix (URS, ES & EDST)
If you would like to join our team of the top engineering and project management experts in the regulated industry, please submit your CV to email@example.com (indicating the job title in the subject line).
Alternatively, to apply for a job, you may submit your CV via mail or fax to:
Stericycle GxP Solutions
About the Company
Stericycle GxP Workforce provide the best engineering experts in their field; experts who like the variety and challenges of working in new and innovative environments; who get the job done and have pride in their achievements.
Located in Cork, Ireland and with customers across global sites, we can offer our Engineers a great place to work with excellent working conditions. Our customers are responsible for some of the most significant medtech & pharmaceutical products of our time, so the projects that our people work on can directly affect patients and improve their quality of life.