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Computer Systems Validation Engineer (CSV)

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We currently have a requirement for a Computerised Systems Validation Engineer (CSV) to join our Data Integrity team. The purpose of this role is to provide CSV support to business systems projects, ensure systems are maintained to meet regulatory expectations and provide SME expertise for CSV, data integrity and associated training.

KEY ACCOUNTABILITIES:

  • Work with internal customers to ensure that their quality and regulatory requirements are being achieved.
  • Conduct and support audits of internal systems and suppliers.
  • Provide CSV SME support to internal customers on business infrastructure/core systems.
  • Identify and communicate regulatory compliance observations on computerised systems to internal management.
  • Define, risk based validation approach for new and changes to existing systems.
  • Ensure system lifecycle documentation is managed, controlled and updated.
  • Maintain up to date knowledge of related regulations and best practices.
  • Ensure systems and infrastructure are developed and validated to meet the requirements of EU Annex 11, FDA 21 CFR Part 11, Part 820 and also other relevant regulatory requirements.
  • Author, review and/or approve validation deliverables such as User requirements, Specification traceability matrices, protocols and reports.
  • Conduct periodic reviews and gap analysis of business systems.

ESSENTIAL KEY ATTRIBUTES:

  • Educated to degree level or equivalent in science or engineering subject or 5 to 10 years of experience in the medical device/pharmaceutical industry conducting software validation.
  • Current knowledge of industry practices and regulations (21 CFR parts 11, 820 and Annex 11, ISA-95) and the application of these within systems.
  • Significant experience in the validation of regulated computer systems applications and infrastructure (e.g SAP, LIMS, MES, SCADA etc).
  • Excellent communication (with all levels of the company, internal and external) and inter-personal skills, to enable the job holder to motivate colleagues, support other areas and influence at a senior level.

DESIRABLE KEY ATTRIBUTES:

  • Audit experience. (Preferably to ISO 13485 or Pharmaceutical QMS).
  • Experience in Programmable logic controllers (PLC), vision systems, Excel spreadsheets validation
  • Good experience in the use of SQL/Oracle and the development/design of databases.
  • Fundamental Knowledge in the validation of process control systems and laboratory systems.

Please send your full application to Careers@Bespak.com

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