|Job Ref:||204601184||Employer:||cv-library.co.uk||Industry:||Civil and Structural||Job Type:||Permanent||Country:||United Kingdom||City:||Shannon||Address:||Post Date:||02/10/2016 02:21|
Job Title: Validation Engineer |
Location: Shannon, Ireland
Carbon60 are working with a leading manufacturer of automation equipment based in Shannon Ireland. As part of their extensive growth plans they are looking to appoint a Validation Engineer.
As the Validation Engineer you will be responsible for the following:
Generate validation documentation including risk assessments, traceability matrix and validation plan/reports.
Development and review of software validation test protocols including FAT & SAT protocols.
Participate in FAT and SAT protocol execution, as necessary.
Collate and organise all qualification files for the project (including Test protocols, Reports etc.)
Document, Investigate and report all deviations/exceptions during the qualification activities.
Co-ordinate qualification activities with contractors and vendors as required.
Efficient management of priorities
To be considered for the role of Validation Engineer you must have the below skills and experiences:
Primary Degree BSc / BEng
Experience in a validation role in either Medical Device or Pharmaceutical Industry.
Knowledge of Computer System Validation including GAMP 5, 21 CFR Part 11 and cGMP requirements
Proven track record in developing validation document for the pharmaceutical and medical device industry
Proactive and solutions focused with good organisational skills
Ability to multitask and manage multiple projects simultaneously.
Excellent communication skills
Excellent technical skills including proficiency in Word, Excel, PowerPoint & MS Project.
For more information on this role please contact Louis Bye on NA