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Vacancy Details

Engineering & Technical

Manufacturing Software Validation Engineer - Tipperary

Contract Type: Permanent
Sector:
Location: Tipperary
Date: 27/01/2017
Job Reference: 86698

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

("manufacturing" OR "fabrication" OR "manufacture" OR "manufacturer" OR "factory" OR "assembly" OR "construction" OR "lean" OR "production" OR "process" OR "packaging" OR "plant" OR "supply chain") AND ("software" OR "s/ware" OR "it" OR "ict" OR "applications" OR "information technology" OR "crm" OR "erp" OR "cloud" OR "application" OR "saas" OR "digital" OR "web" OR "j2ee" OR "tech" OR ".net" OR "sdlc" OR "testing" OR "app" OR "sap") AND ("validation" OR "Validation" OR "valid" OR "verification" OR "manufacturing process" OR "gmp" OR "manufacturing practice" OR "IV&V" OR "performance qualification" OR "design qualification" OR "installation qualification" OR "operational qualification") AND ("engineer" OR "beng" OR "b.eng" OR "designer" OR "eng" OR "engineering" OR "engineers" OR "engr" OR "engineered" OR "enginneer" OR "eng." OR "meng" OR "scientist" OR "technician" OR "technical") AND ("validation" OR "Validation" OR "valid" OR "verification" OR "manufacturing process" OR "gmp" OR "manufacturing practice" OR "IV&V" OR "performance qualification" OR "design qualification" OR "installation qualification" OR "operational qualification") AND ("method validation") AND ("software validation") AND ("design for debug" OR "DFx" OR "DFD" OR "DFT" OR "Design for Test" OR "design for testability" OR "intelligent failure analysis" OR "Design for Debuggability" OR "scan chains" OR "Design for excellence" OR "design for x" OR "Design for Manufacturability" OR "Design for Reliability" OR "design for manufacturing" OR "Design for Six Sigma" OR "DFSS" OR "Design for 6 Sigma" OR "DMADV" OR "IDOV" OR "dfr") AND ("labview" OR "lab view" OR "laboratory virtual instrument engineering workbench" OR "system design platform" OR "national instruments" OR "G" OR "data acquisition" OR "instrument control" OR "industrial automation") AND ("electronic engineering" OR "electrical engineering" OR "computer science" OR "systems engineer" OR "electronic circuits" OR "devices" OR "electrical components" OR "embedded systems" OR "semiconductor devices") AND ("electrical engineer" OR "mechanical engineer" OR "project engineer" OR "electrical" OR "electrical technician" OR "electrical engineering" OR "engineer" OR "electrical enginer" OR "software engineer" OR "electrical design engineer" OR "controls engineer") AND ("software engineering" OR "software engineer" OR "computer science") AND ("tipperary" OR "clonmel" OR "limerick")




Clients we are proud to work with

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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources
Pivot

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 


Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King
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Clients we are proud to work with

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