CSV Engineer

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CSV Engineer

The focus of the Computer Systems Validation (CSV) Engineer is to identify or create industry best practices and implement these within the framework of existing GAMP regulations. Responsibilities of the CSV Engineer will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP (Good Manufacturing Practices) documentation revisions as well as ownership of department procedures. The position provides guidance to junior team members.

 

Key Accountabilities:

  • Lead efforts between internal customers and CSV to ensure assigned activities are prioritized, communicated in an effective and timely manner, and completed on time.
  • Accountable for maintaining full knowledge of the organization's policies/procedures, 21 CFR Part 11, Data Integrity, ICH Q7A requirements and GAMP and the underlying principles of each.
  • Perform all aspects of QMS (Quality Management System) processes (Change Control, Deviation, CAPA) as well as Validation Maintenance of computerized systems.
  • Participate in audits and inspections as a Subject Matter Expert.
  • Own, revise and maintain CSV SOPs.
  • Mentor and train junior members and CSV Specialists
  • Execute all responsibilities as the CSV owner for significant site and process improvement projects, to ensure compliance to appropriate regulatory requirements and industry standards while maximizing efficiency.
  • Oversee all CSV lifecycle activities
  • Function as CSV subject matter experts in Inspections and Audits

 

Key Requirements:

  • Bachelor’s degree or equivalent experience required.
  • MES and Electronic Batch Record experience required, Syncade and DeltaV preferred.
  • Significant Biotech/Pharma or biologics industry experience desired.
  • Knowledge of quality processes and experience with validation of computerized systems.
  • Knowledge of GMP regulations.

 


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