Return to Job Search
Collins McNicholas Recruitment & HR Services Group


Collins McNicholas Recruitment & HR Services Group

  • Cork / Limerick / Nationwide
  • Negotiable
  • Contract
  • Updated 16/07/2012
  • Joann McGlinchey
this job is expired
Apply Now




Position Summary

Computer Software Validation Engineer will have primary responsibility for Quality Assurance activities associated with :-

-       Manufacturing Equipment/Automated Systems

-       Computer Systems

Key Areas of Responsibility

  • Have knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local Procedures as they relate to Computer Systems/Software Validation activities.
  • Participate on Divisional Validation Team to develop and revise Computer Systems/Software Validation Procedures and templates to ensure that current regulatory compliance and Company Objectives are maintained.
  • Participate on both Corporate and Divisional Validation Teams to discuss/feedback and approve revisions to Validation Procedures
  • Represent validation from a Computer Systems/Software Validation perspective at both internal and external audits. 
  • Ensure that QE’s and Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
  • Provide assistance where required with the preparation/testing of validation protocols, and all associated documentation for equipment/systems.   
  • Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems/Software Validation perspective to ensure their continued validated/qualified state.
  • Ensure that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.
  • Review/Approval of all Computer Systems/Software Validation Documentation.
  • Ensure that Validation Logging System is maintained, tracking Validations, Validation Files and ensuring accessibility when required.
  • Assist in the evaluation of the validation status of contract manufacturers and provide guidance where needed. Review validation documentation from contract vendors ensuring that company requirements are met.
  • Work with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures.


Qualifications Knowledge Skills

  • A thorough working knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements.
  • Bachelor’s Degree in Science /Engineering is required.
  • Minimum of 3 to 4 years direct experience in a computer system/software validation role in either Medical device or Pharmaceutical Industry.
  • A thorough working knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements. 
  • High level of PC skills required.
  • The successful candidate must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
  • Working Knowledge/experience of Risk Based Techniques.
  • Excellent communication skills and attention to detail.
  • An understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&Rs an advantage.
  • Have a good understanding of engineering and machine tool fundamentals.
  • Source Code review experience a distinct advantage.
  • Self starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
  • Must be willing to work as part of a multi-site team, be able to travel as part of the job.

For additional information please contact Joann on 021-4809118 or email

Ref: CJ36882
Apply Now
Report This Job

Collins McNicholas Recruitment & HR Services Group

Collins McNicholas Recruitment & HR Services Group


View Agency Profile

Show More


Please enter your email address

Please enter a valid email address

We use cookies to customise our website for you, giving you the best possible user experience. If you continue without changing your settings, we’ll assume that you are happy to receive this personalisation. Find out more about our cookie policy

Accept & Close