CSV Engineer (contract) - Norfolk
|Job Title:||CSV Engineer (contract) - Norfolk|
|Contact Name:||Nathan Wilson|
|Job Published:||July 23, 2017 13:52|
- 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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