Validation Engineer
Phillips-Medisize
- Letterkenny, Co Donegal
- Permanent
- Full-time
- Coordinate and lead validation projects and discussions.
- Work with project teams to define the validation strategy.
- Draft MVPs, equipment qualification, protocol/test cases, deviations and summary report documentation for your projects.
- Execute computer system/software validation activities.
- Interface with customers to resolve issues and harmonize validation requirements.
- Learn and deploy SAP related tools and deliverables associated with validation documents and document approval workflows.
- Provide statistical analysis support to sites and validation teams.
- Assist with training on WI, SOP, and other necessary documents needed to perform validation work.
- Support global rollout of Global Validation requirements and on-site or desk audits of Phillips-Medisize sites to ensure compliance to the global standards.
- Share validation best practices information and suggest improvement opportunities for MPS guidance documentation to process champions
- Travel to other Phillips-Medisize and vendor sites (up to 20%).
- Safety/Environmental: Where applicable, individual is pre-planning safety into work activities to improve performance, proactively identifies safety concerns, complies with Environmental Management System Program SOP's/WI, Policy & Program elements and encourages responsible use of resources
- Bachelor's Degree from an accredited college or university or sufficient work experience in engineering or technical field.
- 1-year minimum experience working in a regulated manufacturing environment, medical manufacturing preferred.
- Strong organizational, and problem-solving skills
- Excellent communication skills and ability to create technical documents
- Competence with Microsoft Outlook, Word, Excel, and PowerPoint
- Good project management and leadership skills
- Self-motivation and the drive to complete projects on time every time
- Working knowledge of medical device assembly and inspection equipment