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Validation Technician II

Job Title: Validation Technician II
Contract Type: Permanent
Location: Tipperary
Industry:
REF: 86385
Job Published: over 1 year ago

Job Description

Contact: Aoife O'Reilly
Email: aoife@hero.ie
Telephone: 091730022

Validation Technician II
Our client, a leader in the Medical Device industry, are looking to recruit a Validation Technician II for their site in Co. Tipperary.

Purpose
Responsible for the design and execution of validation documents, programs and strategies to support the implementation of the Validation Master Plans at the facility. Assist in execution of validation and qualification activities. Work with production teams to give guidance and assistance regarding documentation and requirements for test method validation, process validation, facility, utility and equipment qualification, software validation, raw material and commodity qualification.

Key Role
  • The execution and completion of test, software, process, systems and equipment validations and revalidations in accordance with Validation Master Plans.
  • Reviews or develops processing and/or manufacturing instructions.
  • Maintains detailed documentation through all phases of development, testing and analysis in the company's tracking databases and systems.
  • Work with cross functional groups to improve lean efficiency's and validation timeline efficiency's and reduction in production downtime.
  • Represent the group in production meetings and cross site meetings.
  • Prepare, execute and complete Validation Protocols and Reports, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
  • Performs tests, analyzes data and writes reports and has an ability to work from schematics, engineering drawings, and written or verbal instructions.
  • Monitor the progress of validation projects on a daily/weekly basis ensuring that there is continuous drive/focus on meeting schedules.
  • Performs routine and some non-routine technical assignments using standard methods and sequences. Assignments require limited judgment in troubleshooting proven processes.
  • Work with quality, manufacturing engineering and operations, providing improvement feedback and assisting with resolution of quality and manufacturing issues.
  • The candidate should have a good knowledge in validation documentation with proven problem solving abilities. The ideal candidate would have previous knowledge in regulated documentation lifecycle environment and have experience in electrical testing of electronic and mechanical devices.
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Qualifications: Level 7 technical qualification in electronic engineering or related discipline

For further information on this Product Validation Technician II role in Clonmel please contact Aoife O Reilly on 091730022 / aoife@hero.ie
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