Computer Systems Validation Engineer
- Recruiter
- Confidential
- Location
- Runcorn
- Salary
- Competitive
- Posted
- 22 Sep 2020
- Closes
- 06 Oct 2020
- Sectors
- Engineering
- Contract Type
- Permanent
- Hours
- Full Time
CSV Specialist - North Wales
Pharmaceutical company that specialises in sterile injectable products
The Company are looking for a Computer Systems Validation Engineer to develop CSV Engineering systems within Production Operations on a permanent basis.
Key responsibilities:
Accountability for the development and Validation of Computer Systems/Software Validation Procedures to ensure that current regulatory compliance and company objectives are maintained.
Act as change owner for all GxP IT systems, including risk identification and mitigation, responsible for tracking changes through to completion.
Preparing and executing validation protocols, reports and effectiveness reviews
Provide IT support and assessment for relevant quality deviations. Recommend and manage corrective and preventive actions (CAPAs) to improve IT compliance.
Author SOPs and Work Instructions relevant to the operation, maintenance and compliance of IT systems.
Responsible for working with IT staff to maintain the compliance of IT systems throughout the lifecycle in accordance with site policies and procedures including periodic review.
Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new IT projects throughout the project lifecycle
Validation planning.
Represent IT at internal and external audits.
Work with QA Validation department to ensure alignment between IT compliance processes and site validation policies.
Prepare operational budget and capital expenditure budget for IT projects.
Research and implement new technologies.Knowledge and experience:
Proven experience in a Pharmaceutical, Life Science or similar environment.
Proven experience with respect to Computer Systems Validation/5 Years in a sterile environment
Experience in Trackwise
An understanding of IT Infrastructure and Networks, and IT Qualification activities.
An understanding of Electronic Records and Electronic Signatures, e.g. USA 21 CFR Part 11, EU GMP Guidelines, Chapter 4, Annex 11 and GAMP 5.
An understanding and appreciation of a Quality Management role within an IT Organisation, in particular the Software Development Life Cycle (SDLC), including System Planning, Specification, Design, Testing, and Configuration Management.
An appreciation of auditing IT/IS suppliers with respect to a Software Quality Management System.
Able to create and execute project work plans and revises as appropriate to meet changing needs and requirements to timelines and to budget.
An understanding of databases, e.g. Access, and spreadsheets. Please apply now to be considered
Pharmaceutical company that specialises in sterile injectable products
The Company are looking for a Computer Systems Validation Engineer to develop CSV Engineering systems within Production Operations on a permanent basis.
Key responsibilities:
Accountability for the development and Validation of Computer Systems/Software Validation Procedures to ensure that current regulatory compliance and company objectives are maintained.
Act as change owner for all GxP IT systems, including risk identification and mitigation, responsible for tracking changes through to completion.
Preparing and executing validation protocols, reports and effectiveness reviews
Provide IT support and assessment for relevant quality deviations. Recommend and manage corrective and preventive actions (CAPAs) to improve IT compliance.
Author SOPs and Work Instructions relevant to the operation, maintenance and compliance of IT systems.
Responsible for working with IT staff to maintain the compliance of IT systems throughout the lifecycle in accordance with site policies and procedures including periodic review.
Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new IT projects throughout the project lifecycle
Validation planning.
Represent IT at internal and external audits.
Work with QA Validation department to ensure alignment between IT compliance processes and site validation policies.
Prepare operational budget and capital expenditure budget for IT projects.
Research and implement new technologies.Knowledge and experience:
Proven experience in a Pharmaceutical, Life Science or similar environment.
Proven experience with respect to Computer Systems Validation/5 Years in a sterile environment
Experience in Trackwise
An understanding of IT Infrastructure and Networks, and IT Qualification activities.
An understanding of Electronic Records and Electronic Signatures, e.g. USA 21 CFR Part 11, EU GMP Guidelines, Chapter 4, Annex 11 and GAMP 5.
An understanding and appreciation of a Quality Management role within an IT Organisation, in particular the Software Development Life Cycle (SDLC), including System Planning, Specification, Design, Testing, and Configuration Management.
An appreciation of auditing IT/IS suppliers with respect to a Software Quality Management System.
Able to create and execute project work plans and revises as appropriate to meet changing needs and requirements to timelines and to budget.
An understanding of databases, e.g. Access, and spreadsheets. Please apply now to be considered