CSV Engineer

Team Horizon is seeking a CSV Engineer on behalf of our client, who are a leading manufacturer of healthcare products which are used globally. This role will support a SAP Deployment project and is an initial 12 month contract.

Why you should apply:

• Excellent opportunity to utilise CSV & SAP experience


• This role offers the flexibility to work remotely or on site

What you will be doing:

• Ensure all Computerized system applications are qualified in compliance with company policies and procedures, FDA, European cGMP and GAMP standards.


• Co-ordinate, provide guidance and actively participate as a project team member for software validation projects.


• Generation/maintenance of software validation plans, protocols and reports to cGMP standard.


• Review / approval of software validation plans, requirements, protocols/ test scripts and final reports.


• Management of software validation change control process.


• Serve as validation SME providing guidance and direction to lead validation activities for software projects.


• Represent validation team at both internal and external audits and at Quality System Management Reviews when applicable.


• Responsible for the overall administration of the document control program related to software validation.

What you need to apply:

• Experience working with computer systems, software validation, or related field is essential


• Computer Systems Validation experience and understanding of applicable regulations (Annex 11, GAMP, 21 CFR Part 11).


• Regulated environment, medical devices experience is preferable.


• Bachelor’s Degree in a scientific or engineering discipline required


• Good knowledge and understanding of the medical device quality and regulatory requirements, including ISO13485, GAMP 5, IEC62304, 21CFRpart 820, part 11 as well as other Computer System Validation processes.


• Demonstrated working knowledge in the principles and effective implementation of software validation methodology.


• Experience in the review, evaluation and testing of systems to ensure compliance with FDA Electronic Records/Electronic Signatures regulations.


•  Good overall knowledge with IT infrastructure and applications


• Strong oral, written communication, and interpersonal skills.


• Ability to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned project goals.


• Must be results driven striving to meet all targets and prioritize/manage project deliverables.