CSV Engineer (contract) - Norfolk

CSV Engineer (contract) - Norfolk

Job Title: CSV Engineer (contract) - Norfolk
Contract Type: Contract
Location: Norfolk, England
Salary: Negotiable
Start Date: ASAP
Reference: CSVENG_1500814332
Contact Name: Nathan Wilson
Contact Email:
Job Published: July 23, 2017 13:52

Job Description

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.

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