CSV Engineer

Posted on: 12/04/2018
Ref: VAC-16445
 
  • Country: Ireland
  • Location: Meath
  • Industry:
  • Discipline:
  • Employment Type: Contract
  • Duration: 52 weeks+

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Job Description

A CSV Engineer is required to work with our client based onsite in Dublin to provid CSV support on the process automation of a major biotech project, implementing new technologies and developing industry leading manufacturing information systems.

The CSV Engineer will work within a CSV team for a new biologics facility. The projects will include the qualification of plant computer systems such as Delta V, new plant equipment and also up-grades to existing computer systems and equipment

PRIMARY RESPONSIBILITIES:
– Write and review of Computer System Validation Test Protocols and Summary reports
– Participate in GMP Risk Assessments and FMEA’s, compliance review of Risk Assessment documentation
– Ensure equipment changes are implemented as per change control procedures
– As part of team co-ordinate & communicate of validation issues to team member

EDUCATION AND EXPERIENCE:
– Degree in Engineering/Science Discipline
– 3+ years experience in a similar role
– Delta V DCS background/experience is preferred
– Experience in computer system validation essential
– Good working knowledge of Regulations and Guidelines, GAMP 5 requirements and ISPE Guidelines
– Experience in the Pharmaceutical/Biotechnology industry
– Ability to participate in cross functional teams

Please contact Kathy for full details on these role on 021 4777329 or kgillen@lsc.ie or apply directly through this advert

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