Connecting to LinkedIn...

Vacancy Details

IT/Software

Software Validation Engineer - Galway

Contract Type: Permanent
Sector:
Location: Galway
Date: 10/07/2017
Job Reference: 88861

Job Description

Contact: Catriona Coogan
Email: catriona@hero.ie
Telephone: 091730022

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


Responsibilities:
  • The Software Validation Engineer is a member of the validation team in the Quality department of the company. S/he is primarily responsible for documentation and execution of validation activities in accordance with validation plans and procedures. This position is primarily based in our Galway facility.
Qualifications:
Job Responsibilities:
  • Includes the generation, development, modification, and routing of Validation Protocols, Final Reports, Standard Operating Procedures, and Change Controls, as they relate to software system or computerised system qualifications.
  • Troubleshoot validation issues associated with validation projects.
  • Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to computerised systems to ensure the validation status of the system is maintained.
  • Ensure validation documents are up-to-date (primarily MVPs).
  • Ensure all results and data are correct and follow-up on any gaps or discrepancies.
  • Liaise with the functional owners to ensure that computerised system validation requirements are maintained from Purchase to Qualification.
  • Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions.
  • Maintain validation procedures and templates up to date, focusing on continuous improvement.
  • Mentor personnel with respect to software and computer validation.
  • Any other duties as required.
Key Requirements:
  • Degree in Software Engineering or Science/Engineering with 3+ years' experience in a similar role within the Medical Devices or related Healthcare industry.
  • Strong knowledge of ISO and FDA quality requirements. Knowledge of electronic records requirements/compliance protocols (cGMP, GMP, FDA regulations, 21 CFR Part 11, 210, 211 and 820 compliance).
  • Experience with IQ, IOQ, OQ, PQ and Validation Summary Reports as they relate to ERP system qualification.
  • Experience in the validation of PLC, SCADA and HMI.
  • Understanding of validation principals and techniques for software and computerized systems as applied in the medical device industry.
  • Good understanding of validation concepts and documentation.
  • Strong communication skills, including ability to advice and influence.
  • Excellent attention to detail and report-writing ability.
  • Proven ability to work on own initiative.
  • Highly organized with strong ability to prioritize tasks.
  • Ability to provide subject matter expertise during inspections and regulatory audits.

For further information on this Software Validation Engineer role in Galway please contact Catriona Coogan on 091730022 / catriona@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



Share this Job

Our Clients

With a reputation across three decades in the making, HERO Recruitment continues to impress our clients and candidates with our passion and dedication to our craft.

See More

What people say

Our strong reputation for quality placements in key roles has earned us the status of agency of choice. HERO Recruitment’s commitment to superior service is what sets us apart from our competitors and has rewarded us with many exclusive and semi-exclusive client and candidate relationships.  Here is what our clients and candidates say about us…

See More

“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

“Merit Medical have partnered with Hero for the past 10 years. During this time we have grown our employee numbers to 630 employees. Our experience of working with HERO is that they have a personal client focused approach, they know the market and they can deliver on the candidates.  The medical device market is competitive and our company success is dependent on the quality of our people, we want the best there is in the market so we can grow and in turn offer development opportunities to our people. 

Mary Collins,
Senior Director, Human Resources Europe
Merit Medical

“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