Engineering & Electronics

CSV Lead

  • Contract
  • Remote
  • Midlands
  • 41922834

PE Global is currently recruiting for a CSV Lead for an initial 12-month contract role with a leading multinational pharmaceutical client based in Runcorn.

Job Responsabilities:

  • Establish the validation and compliance strategies and approaches within the site local projects
  • Ensure adherence to company standards and applicable regulatory requirements and practices
  • Advise on Data Integrity
  • Validate manufacturing systems, Laboratory Systems and Business Systems
  • Work under pressure and to strict deadlines
  • Provide weekly updates to the CSV Manager and escalate any issues as they occur
  • Maintain, develop, implement and monitor site policy and procedures for CSV to ensure that they reflect current industry thinking and are compliant to cGMP, client’s corporate policies & quality standards manual and regulatory guidelines
  • Perform periodic reviews of computer systems
  • Assist in the implementation of the site Data Integrity programme
  • Perform remediation of computer systems
  • CSV Lead for new projects (this includes LabX, Laboratory Monitoring System, building management system, Serialisation, facility monitoring system, various manufacturing and lab systems)
  • Generation of computer validation documents (e.g. Val Plan, Functional Design Specification, IQ, OQ, ERES, DRP)
  • Co-ordination of CSV related activities
  • Ensure the client’s Computer System Site Inventory is periodically reviewed and kept current.
  • Conduct periodic internal-audits to the implementation
  • Represent the computer systems validation approach to regulatory authorities during inspection.


  • Minimum of degree in a relevant discipline.
  • 10 years’ experience of CSV in a pharmaceutical manufacturing environment. (with a minimum of 5 years in a lead CSV role)
  • Extensive experience working with manufacturing system (i.e. PLC/SCADA), Lab systems and business information system
  • Experience in preparation and presenting information during FDA/MHRA
  • Excellent understanding of the regulatory expectations relating to CSV.
  • A broad understanding of validation principles in general and the GMP expectations as applicable.
  • In depth knowledge of GAMP
  • An understanding of Data Integrity in line with recent regulatory expectations.
  • Proven ability to plan resources and manage priorities to consistently deliver on time against tight project timelines.
  • Well-developed communication skills with the ability to persuade and influence all levels of colleagues, regulators and industry specialists.
  • Good Understanding of Aggregation and Serialisation
  • Good communication skills and the ability to train people in CSV

Interested candidates should submit an updated CV.
Please click the link below to apply, call Veronica on +44 20 3966 9800 or alternatively send an up to date CV to

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***

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