Lead CSV Engineer

Posted By: George Hixon
Salary: Competitive salary
Location: Teesside (Semi Remote)
Job Type: Permanent
Category: Information Technology, Pharmaceutical

Central Employment are thrilled to be working with a leading pharmaceutical business based in the North East of England. Due to extensive growth, I’m looking for Lead CSV Engineer in a permanent capacity. This is a senior opportunity that will suit those with extensive CSV experience from automation preferably within pharmaceuticals. You will be instrumental in the CSV process and will act as a subject matter expert for the business. GAMP 5 knowledge is essential for this role.

This is a permanent role

Key Responsibilities

  • Ensure all computerised systems are validated correctly
  • Provide project teams with expert computerised system validation guidance and definition of appropriate CSV strategies
  • Preparation and review of all levels of validation documents including Validation Plans, User Requirement Specifications, Design Specifications and SOPs
  • Qualification Documents (DQ, IQ, OQ, PQ, FATS/SATS
  • Provide training on Computerised System Policies including industry regulation trends
  • Audit as CSV subject matter expert, suppliers of computerised systems or external partners

Essential Requirements

  • At least 5 years’ experience of GAMP, risk-based approach to validation
  • Knowledge of data management and data integrity needs within a GMP regulated environment
  • Demonstrable project work on automated systems CSV requirements
  • Carried out supplier audits as Subject Matter Expert within CSV
  • Defined validation strategies for system upgrades and new system implementations

The Person

  • Self-motivated, flexible and able to work under pressure
  • Excellent management, documentation and communication skills
  • Strategic thinking, concern for standards ability to empower and influence

This is a fantastic opportunity to join a global business going through a significant period of change.

 

Apply Now!

Personal Details

Curriculum Vitae

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