Your Job
Your role will support Operations and Project teams in the completion of projects to meet customer, regulatory and manufacturing requirements.
Our Team
Our Technical Services Team is seeking a Validation Engineer to support operations in our Sligo, Ireland location. This role will manage, organize, and coordinate the activities of Validation Engineers with the goal of maximizing company profitability by providing products/services that meet customer expectations. Support manufacturing in the effort to ensure optimum validation of projects/programs to meet customer, regulatory and manufacturing requirements.
What You Will Do
* Work with project teams to draft protocol and test case documents.
* Help to qualify manufacturing equipment to be used in validated processes.
* Draft deviations and develop summary reports for project wrap ups.
* Lead low-complexity validation projects.
* Learn and deploy SAP related tools and deliverables associated with validation deviations, customer approvals, and document approval workflows.
* Suggest creative validation process improvement opportunities.
* Provide statistical analysis support.
* Assist with creating, updating and 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.
* Travel to other Phillips-Medisize and vendor sites as needed (up to 10%).
Who You Are (Basic Qualifications)
* Demonstrated good communication, teamwork, and organizational skills.
* Striving for continuous development.
* Problem-solving and statistical process control skills.
* Can work independently.
* Decision-making skills.
* Fluent English language skills.
* Good knowledge of MS Office applications (Excel, Outlook).
What Will Put You Ahead
* Knowledge of quality management systems in accordance with ISO 9001 and 13845, GMP.
* Experience in a GMP environment.
* SAP proficiency.
* Minitab, incl. DoE analysis.
* Third level Studies in Quality or Validation fields.
Who We Are
As a Molex company, Phillips-Medisize mobilizes and deploys specialized capabilities and services across highly regulated industries, including health care, regulated consumer, automotive and defense. We design, develop and create innovative and life-changing medical technologies for millions of people around the globe.
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.
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