Validation Engineer

• Validation Engineer
• Runcorn - fully on-site
• £40k - £50k + 10% annual bonus

Our client is on the lookout for a Validation Engineer who will assist in the coordination of company's computer systems validation projects. The person will have an opportunity to work with internal and external parties to produce high quality solutions to critical business and regulatory requirements. The Validation Engineer will ensure that all Quality and Regulatory business needs and deadlines are met.

Main Accountabilities

• Work with relevant Change Owner for all GxP IT systems, including risk identification and mitigation, responsible for tracking changes through to completion.
• Preparing and executing CSV deliverables, such as validation protocols, reports and periodic reviews
• Provide system support and assessment for relevant quality deviations. Recommend and manage corrective and preventive actions (CAPAs) to improve system compliance.
• Author SOPs and Work Instructions relevant to the operation, maintenance and compliance of software systems.
• Responsible for working with IT staff and Process Owners to maintain the compliance of IT and software 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 software projects throughout the project lifecycle. This includes updating of the dynamic Validation Master Plan.
• Validation planning.
• Support CSV at internal and external audits.
• Work with the rest of Validation department to ensure alignment between CSV compliance processes and site validation policies.
• Research and propose new technologies for implementation.
• The role holder must comply with policies or procedures relating to data privacy or information security.

Experience and Qualifications

• Proven experience with respect to Computer Systems Validation or higher education qualification in computer science or related subject.
• An understanding of IT Infrastructure and Networks. An understanding of IT Qualification activities would be beneficial.
• 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
• An understanding of databases, e.g. Access, and spreadsheets.
• Being able to write/review code would be extremely beneficial.

Benefits:

• 10% annual bonus on top of the salary
• 25 days annual leave + bank holidays
• Pension scheme
• Extended maternity and paternity leave
• Health plan