As a CSV Engineer, you will be working to ensure conformance to quality systems, to liaise with various departments, and give guidance, review documentation and ensure the company validation policies & procedures are being adhered to
• Support a multi-year software lifecycle management initiative to refresh GxP applications across manufacturing and Labs
• Support upgrading custom and COTS applications by authoring change controls, risk assessments, integration protocols, test scripts and summary reports and by updating SOPS and training material as required
• Provide guidance to the project team on up-to-date and relevant regulatory requirements and will work closely with other members of the project team and business process owners to ensure upgrades are executed and delivered in a timely manner
• Other duties as required
• A degree qualification in engineering, information technology or relevant engineering discipline is required.
• Experience in GMP or GLP regulated environment essential.
• 3 years CSV experience
• A strong background in software development and test with in-depth understanding of relevant GAMP and relevant EU/FDA regulations around software and data systems.
• Excellent verbal and written communications skills
• The ability to collaborate effectively with the various stakeholders
Why Join Crest Solutions?
In Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Crest Solutions benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows:
- Competitive salary
- Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme
- A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment
- A structured approach to professional development opportunities with an educational assistance programme
Crest Solutions is an equal opportunity employer.