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Vacancy Details

Engineering & Technical

Validation Engineer - Cork

Contract Type: Contract
Sector:
Location: Cork
Date: 22/12/2016
Job Reference: 82371

Job Description

Validation Engineer

Our client, a medical device company in Cork are currently looking to recruit a Validation Engineer for their site on an hourly contracting basis.

JOB PURPOSE
The Validation Engineer, plays a key role in the planning and execution of validation activities related to new product introductions, product transfers and process changes. Provide support for the validation activities associated with equipment & processes ensuring that all compliance issues and requirements of Company validation policies and procedures are addressed.
Act as Subject Matter Expert (SME) on the validation process and deliver coaching and training as required.

MAIN DUTIES & RESPONSIBILITIES:
  • Act as Subject Matter Expert on the validation process for the site
  • Contribute to the planning and execution of validation activities related to new product introductions, product transfers and process changes
  • Work as an integral member of project teams to provide guidance and support in establishing optimal validation approach and/or strategy
  • Provide technical assistance to carry out problem solving analysis / root causing investigation
  • Create, execute and review validation related documents, including but not limited to: Protocols, Reports, Change Controls, Validation Plans, etc. in line with site and organizational procedures
  • Maintain the validation process in a state of compliance with external regulatory requirements as well as JnJ Standards, while focusing on continuous improvement driving to a best-in-class validation process
  • Support the presentation of executed validation documentation during audits and/or other reviews of the validation process
  • Operate within the company's SOPs and ensure GxP compliance is maintained at all times


KEY COMPETENCIES REQUIRED:
  • Excellent Communication Skills
  • Pro-active approach to work
  • CrossfunctionalTeam Player
  • Flexible & Adaptable
  • Highly computer literate
  • High attention to detail
  • High work standards
  • Planner & organiser
  • Active listener

QUALIFICATIONS & EXPERIENCE

EXPERIENCE ESSENTIAL:
  • Degree Engineering or Science Discipline
  • Minimum of 3-5yrs experience in Quality Assurance/Engineering (a minimum of 2yrs of which has been spent carrying out validations
  • Experience in generation of pFMEA
  • Understanding of Statistical Techniques for assessment of process capability
  • Ability to interpret Engineering drawings/specifications
  • Familiarity in areas of various inspection techniques
  • Excellent interpersonal & communication skills

DESIRABLE:
  • Medical device validation experience, including test method validation - variable and attribute
  • In depth knowledge of 21 CFR Part 820 & Part 11 and European regulations associated with the medical device industry
  • High understanding of GMP, Compliance, Validation practices including the system development life cycle and regulatory expectations
  • Working knowledge of Quality systems (FDA/ISO) within a regulated environment



For further information on this Validation Engineer role in Cork please contact Aoife O Reilly on 091730022 / aoife@hero.ie HERO Recruitment website - www.hero.ie

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

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
More

Clients we are proud to work with

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