Validation Engineer

Validation Engineer

Position Overview:

Phillips-Medisize, Sligo is seeking a Validation Engineer, who will be responsible for coordinating all validation & verification activity of new products introduced to the site, as well as changes to existing products, equipment and processes. This person will ensure the Validation Function is maintenance in line with Corporate Requirements, and in compliance at all times in supporting the compliant manufacture of products for our Customers.

Working within the Quality Group, the successful candidate must have the ability to work within the QMS with minimum supervision, understanding the entire QMS and how each and every process within the system integrates to achieve success at every stage.

S/he will be expected to contribute significantly to the future development and maintenance of the QMS.

Essential Functions:

  • Co-ordinate all validation activity within the company working directly with the Engineering & Operations Departments.
  • Drive successful validation / verification of processes, systems, software and equipment installations and revalidations within the cross functional team.
  • Maintain & publish the Master Validation Plan, highlighting challenges, and identifying solutions to ensure effective and on time execution.
  • Actively contribute within cross functional teams to establish validation strategies and objectives, determination of sampling techniques & statistical analysis, all in line with customer requirements for their products.
  • Prepare and complete Validation Protocols and Reports in support of product & process changes, as well as the new product introduction effort.
  • Build the validation / verification packs for retention on file, to include all supporting material from cross functional areas, e.g. Risk Assessments, Metrology, Process Engineering, and ensure same is always ready for sharing with customers & auditing bodies.
  • Maintain close working relationship with the Quality Engineering team on established products & process, and their ongoing compliance per original validation / verification studies.
  • Provide ongoing guidance and support to all departments relating to process & equipment change control, and the requirements to validate / revalidate.
  • Coordinate & discuss validation activity with customers and in line with their requirements.
  • Monitor the progress of validation projects on a daily/weekly/monthly basis ensuring that there is continuous drive/focus on meeting schedules.
  • Ensure ongoing compliance, as applicable, with ISO13485 and other related Guidance Documents.
  • Embrace the Corporate MBM (Market Based Management) Framework and Guiding Principles.

Required Qualifications:      

  • Bachelor’s degree in Quality Management/ Quality Assurance / Engineering or equivalent industry experience
  • 2 years’ experience in a similar role in the Medical Device Industry.
  • Knowledge of ISO, MDD, FDA requirements essential.
  • Knowledge of Quality Standards, Validation Regulations and Guidance Documents required
  • MS Office proficient. Experience with SAP beneficial.
  • Proven track record in a similar role.
  • Strong project management capabilities.
  • Excellent attention to detail in oral & written communication, with a proven technical protocol & report writing background

With your application you agree that your information will be recorded in our files (up to 6 months after finalizing the position) and if necessary, forwarded to affiliated companies.  

We are an equal opportunity employer.


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