Validation Engineer

Phillips-Medisize

  • Letterkenny, Co Donegal
  • Permanent
  • Full-time
  • 15 days ago
Location(s)Letterkenny, DonegalCompanyPhillips-MedisizeCareer FieldQualityJob Number156026Your JobJoin our Global Technical Services Team as a Validation Engineer.Our TeamOur Global Technical Services Team is seeking a Validation Engineer to support operations in our Letterkenny, 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 at the lowest cost. Support manufacturing in the effort to ensure optimum validation of projects/programs to meet customer, regulatory and manufacturing requirements.What You Will Do
  • 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
Who You Are (Basic Qualifications)
  • 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.
What Will Put You Ahead
  • 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
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.Who We AreAs 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 helps employees unleash their potential while creating value for themselves and the company.Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

Phillips-Medisize

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