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CSV Engineer

Monster
 
 

Job Summary

Company
Life Science Consultants Ltd
Location
Sligo, Sligo
Industries
Biotechnology/Pharmaceuticals
Medical Devices and Supplies
Job Type
Full Time
Permanent
Years of Experience
2+ years
Education Level
Bachelor's Degree
Career Level
Experienced (Non-Manager)
Job Reference Code
VAC-15200_1484148536
Life Science Consultants Ltd

CSV Engineer

About the Job


Looking for a move to a world class medical device facility based in Sligo. Our client has a permanent requirement for a Engineer to work on validation of computers systems, equipment and software.

As a member of the validation team your main responsiblities will be:
  • Ensure all Computerized systems are qualified in compliance with Data Integrity policies and regulatory requirements.
  • Co-ordination / direction and active participation in the validation of site equipment, facilities, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
  • Generation/maintenance of the Validation Master Plans.
  • Generation/maintenance of Project Validation Plans.
  • Generation of validation plans, protocols and final reports to cGMP standard.
  • Review / approval of all protocols and final reports.
  • Management of validation change control process.
  • Adheres to and supports all EHS & E standards, procedures and policies

As a CSV you will need:
  • 3rd level qualification in a relevant engineering or scientific discipline.
  • Minimum of 2 year's experience as a Validation Engineer or related role.
  • Demonstrated ability to operate as sole contributor with a proactive approach to responsibilities assigned. Demonstrated leadership skills in identifying and overcoming challenges.
  • Computer System Validation experience highly desirable.

Contact Kathy at LSC on 021 4777 329 for more details, or apply directly via this advert.
 

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