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Vacancy Details

Engineering & Technical

Senior Systems Validation Engineer - Dublin

Contract Type: Permanent
Sector:
Location: Dublin
Date: 14/08/2019
Job Reference: 105223
Contact Name: Orla Crowley
Contact Email: talent@hero.ie

Job Description

Senior Systems Validation Engineer - Dublin

As the Senior Systems Validation Engineer you will be working to ensure conformance to quality systems, to liaise with various departments, and give guidance, review documentation and ensure the company validation policies & procedures are being adhered to.

Responsibilities
  • Managing and co-ordinating the preparation, review and approval of the Validation Master Plans
  • Managing and co-ordinating of all validation strategies and deliverables
  • Development and maintenance of internal validation policies and procedures based on best international standards and practices
  • Auditing of internal projects against internal validation policies and procedures
  • Managing and co-ordinating the preparation, review and issuing of validation protocols and reports
  • Managing and co-ordinating validation documentation including risk assessments, traceability matrices, and validation reports
  • Managing and co-ordinating the review and approval of specifications associated with Equipment, Processes, Products and Computerised Systems
  • Managing, co-ordinating and directing all validation and revalidation activities
  • Reviewing, managing and approving change control forms for Validation/Compliance implications
  • Managing and co-ordinating routine Internal Quality Audits of the facility to ensure compliance, be proactive in resolving issues which may arise
  • Updating existing quality documentation related to validation activities
  • Identifying training requirements for project team members in support of validation
  • Managing and co-ordinating risk assessments for customer projects
  • Developing and reviewing software validation plans, test protocols, test data and test reports for embedded medical device
  • Provide technical direction in the development and review of software requirements
  • Managing and co-ordinating the design and implementation of software validation processes on projects
  • Work closely with software engineering team to ensure implementation and application of software validation principles throughout the development process
  • Provide technical direction and hands-on assistance for testing projects.
  • Reviewing vendor validation documentation
  • Managing and co-ordinating all project validation activities (including the vendors)
  • Motivates & coaches team to enhance performance
  • Work closely with the commercial department to assist in opening new client opportunities and generation of client proposals
  • Makes articulate and effective presentation to a variety of audiences, large or small, internal or external
  • Effectively communicates and constructively defends results of own work or teams’ work at technical presentations in-house, with clients, and at technical meetings
  • Liaising with customer departments
  • Addressing customer feedback and providing progress updates to customers

Requirements
  • Bachelor’s degree in Computer Science, Electrical Engineering, Systems Engineering, Technology or a related discipline
  • Over 5 years’ experience as a Validation Engineer (mainly computer validation) in the Pharmaceutical or related Healthcare industry
  • Experience of GxP Computerised Systems
  • Industry knowledge of EU GMP (IMB/FDA), Annex 11 Computerised System Validation, ISO quality requirements
  • Familiar with the GAMP5 guidelines
  • Experience with serialization
  • Experience with Systech Technology
  • Excellent communication skills, including ability to advise and influence
  • Excellent attention to detail
  • Excellent understanding of validation concepts and documentation
  • Excellent communication skills, including ability to advise and influence
  • Should be based within a commutable range or else willing to re-locate for 1 year period
  • Expected to be on site during the project with the exception of attendance at any FAT

For further information on this Senior Systems Validation Engineer role in Dublin please contact Anna Carty on 086 816/ careers@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie

Please Note: Under its obligation under the Data Protection legislation, 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

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“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

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager
Valeo

“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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