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Manufacturing Software Validation Engineer

Job Title: Manufacturing Software Validation Engineer
Contract Type: Permanent
Location: Tipperary
Industry:
REF: 86698
Job Published: 8 months ago

Job Description

Manufacturing Software Validation Engineer

Our client, a medical device company in Tipperary are currently looking to recruit a Manufacturing Software Validation Engineer for their site.

Purpose
In this role as a Manufacturing Software Validation Engineer you will be responsible for the design and execution of validation documents, programs and strategies to support the implementation of the Validation Master Plans at the facility. Drive and execution of validation and qualification activities. To provide validation mentoring, support and expertise in the definition, development and test of the complete validation lifecycle for test method validation, process validation, facility, utility and equipment qualification, software validation, raw material and commodity qualification.

Key Role
  • Working with colleagues to design, develop, debug, modify, and validation lifecycle documents and procedures, systems by using current tools, analysis techniques, and technologies.
  • Leading & coordinating Site Validation projects as required
  • Takes ownership of the Software Quality Tasks within the Electronic and Manufacturing teams
  • A strong background in software, test & automation is key to this role. Should be able to work closely with developers who are testing Test and Manufacturing technologies and ideally you have experience understanding code (in any language, ideally C, C#, Labview).
  • Develops test framework and test cases, collaborates with cross functional groups to create and maintain a continuous improvements for test, manufacturing systems and automation
  • Liaise with regulation departments as relevant on the validation/procedures of new automation/tooling/test/processes/software/utilities to ensure that all aspects of validation are being covered for Audit reviews
  • The execution and completion of test, software, process, systems and equipment validations and revalidations in accordance with Validation Master Plans.
  • Providing 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.
  • Maintains detailed documentation through all phases of development, testing and analysis in the 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.
  • Review of validation / qualification plans, protocols, reports, amendments and other validation / qualification records across test, software, process, systems and equipment validations.
  • Provide site training for test method validation, process validation and facility, utility and equipment qualification.
  • 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. Use knowledge of statistics to assist with process improvements, validation developments and process/product investigations
  • Takes ownership of the Software Quality Tasks within the Electronic and Manufacturing teams
  • A strong background in software, test & automation is key to this role. Should be able to work closely with developers who are testing Test and Manufacturing technologies and ideally you have experience understanding code (in any language, ideally C, C#, Labview).
  • Develops test framework and test cases, collaborates with cross functional groups to create and maintain a continuous improvements for test, manufacturing systems and automation
  • Liaise with regulation departments as relevant on the validation/procedures of new automation/tooling/test/processes/software/utilities to ensure that all aspects of validation are being covered for Audit reviews
  • The candidate should have a strong knowledge in validation documentation and lifecycle 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 & Experience
  • Level 8 Degree in Electronic / Electrical or Software
  • Min of 5 years industry experience, validation lifecycle experience preferable

For further information on this Manufacturing Software Validation Engineer role in Tipperary please contact Jenny Mullery on 091730022/ jmullery@hero.ie
Check out all our open jobs on our HERO Recruitment website - www.hero.ie

Please Note: HERO Recruitment will not forward your details to any company without your prior approval

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