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CSV VALIDATION ENGINEER

 

Company:

ENTERPRISE SYSTEM PARTNERS
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Job Reference Number

14566017

Client ID:

RI/CSVMCK
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Posted On:

Feb 6 2012

Location:

CORK/KERRY, MUNSTER
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Job Type:

Contract/Permanent

Salary:

45000 - 60000 DOE
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Benefits:
  • PENSION / PRSA
  • PERM. HEALTH INSURANCE
  • NEGOTIABLE
  • PAID HOLIDAYS
We are a rapidly growing company that needs highly motivated people to help drive it forward. We are currently looking to recruit an experienced Validation Engineer to join our team on a long term contract.

CSV VALIDATION ENGINEER

Remediation software validation effort.

Key Responsibilities:

  • Generate a plan detailing the scope of work and intent.
  • Address Requirements Traceability Matrix (RTM) gaps by:
  • Identifying specific tests in the IQ/OQ that address Requirements. Also detail the scenario’s where requirements were met by the transition of the system from one test step to the next test step.
  • Identify requirements met in the PQ (pointing to specific PBR steps)
  • Generate/Update the existing RTM
  • Ensure all work is in line with the Master Validation Plan
  • Generate summary report
Key Experience:

  • Validation experience in a GMP / FDA regulated environment.
  • Minimum 5 years validation experience
  • CSV experience
  • MES validation experience very advantageous
  • Strong technical writing and communication skills
Education:

Degree level qualification in Science or Engineering.

ABOUT US:

Enterprise System Partners (ESP) Ltd is a highly successful project engineering company, which provides systems support to the life science industry in Ireland for the planning, vendor selection, design and implementation of systems from the automation layer (DCS, SCADA) right up to the ERP layer (e.g. SAP, JD Edwards) with particular expertise in manufacturing and laboratory systems. Our unique strength is our people collectively understand the entire system landscape within the manufacturing environment. This includes expertise in Manufacturing Execution Systems (MES), (including document management systems, maintenance/calibration systems, CAPA systems, Material Tracking Systems, Electronic Batch Records and W&D) and integration of these systems throughout the entire systems landscape. We have offices in Cork and Dublin, with our team based on pharmaceutical plants around the country.