Validation Engineer

Posted 20 August 2021
Salary€40 - €50 per hour
LocationCounty Offaly, Leinster
Job type Contract
DisciplineEngineering Leaders and Specialists
ContactEmma Mullen

Job description

A global distributor and manufacturer of medical supplies and pharmaceutical products. Undergoing global corporate projects currently, seeking an experienced engineer to join their projects team. On a team of 10 engineers, you will report directly to the engineering project manager.

The Role

  • Coordinate implementation of new materials to support the MDR requirements/remediation

  • Support process and product validation executions ensuring validations meet pre-determined acceptance criteria.

  • Critical Process validation protocols and reports - identify the critical validated processes. Provide validation reports that support the validation of the device manufacturing process, testing, and environmental controls.

  • Root cause and problem solve production issues for Manufacturing Machines.

  • Continuous improvement focus, demonstrating strong knowledge of Six Sigma methodologies and applies these tools in the characterization, optimization and troubleshooting of process equipment and technology performance.

  • Continuously communicate status of projects and programs with regard to timing, objectives and roadblocks

  • Work with cross functional teams to ensure objectives and timelines are being met

  • Device Master Records - A thorough process assessment to ensure the process reflects the manufacturing process in line with the DMR

  • Manufacturing flow charts -A detailed overview of the manufacturing processes Identifying any critical processes.

  • Participate in our Risk Management program, identifying the critical to quality characteristics (CTQs) for each product code, quarterly updates to our risk management file

The Person

  • A degree in Engineering / Technical discipline with minimum 3 years relevant quality engineering experience in a medical device/pharmaceutical environment.

  • Process Validation experience essential

  • Experience on projects from conception to completion, cost savings and process improvements will be beneficial

  • Knowledge of Six Sigma & Lean Manufacturing Techniques

For more information, please reach out directly to Emma Mullen on +353 87 636 9263 or