Life Sciences - CSV Lead Engineer - NE Morpeth

CSV lead Role

Our client is a leading Pharmaceutical company based in the UK. A vacancy has been created for a Computer System Validation lead. Working in a small friendly team of IT professionals, reporting to the Head of IT you will provide Leadership and delivery of the CSV process, to achieve regulatory compliance and application adoption into a changing complex IT environment, we operate a GMP based manufacturing facility from API to finished packaged Pharmaceutical goods.

Job overview

The role entails working with our Quality, Validation department, IS teams, and business users to ensure changed and new applications meet and comply with our regulatory needs. Working in a reactive environment, plus assisting project based teams, you would provide both expert CSV analysis and test management using your expertise in validating solutions.

Key requirements

• Conception, process evolution and planning and performing of Computer Systems Validation (CSV) in the regulated environment GMP (Pharma, API, Biotech)
• Subject Matter expert knowledge of national and international regulations and standards, GAMP, ISO 9001, ISO27001, FDA 21 CFR, Part 11
• Advisory and support of business departments to build and maintain all GMP systems needs
• Support during projects handling GMP critical computer systems.
• Support Customer and regulatory audits on site.
• Implementation of qualification / validation activities within projects of new and existing computer systems according to our requirements.
• Conception and implementation of Data holding systems and solutions (working with our Data Integrity program)
• Follow the FAT and SAT models, working with upgrading and patching Computer systems according to internal software Lifecycles and ITIL processes.
• Performing internal and external CSV, SOP improvement and change management.
• Be able to look at process and apply standard model of URS, QP, DQ, IQ, OQ, PQ, relating to CSV Work with the end user, IS teams and validation to test and deploy to an operational state.
• Work with our corporate Information Systems compliance teams to adopt best practice enhancements or deploy a new technologies.

Essential Experience :

• Significant experience in IS in Pharmaceutical manufacturing or Laboratory CSV testing area.
• Knowledge of ERP systems, Laboratory, Manufacturing based systems LIMS, and Quality systems testing.
• Adopt a positive, co-operative, and structured approach to CSV, to get it right first time.
• Able to document, evolve a test plan and communicate a solution to produce an implementable project timeline.
• Working with Vendors and service providers in a GMP regulated industry.
• IT related qualifications and a related Degree desirable.

Benefits

In addition to a competitive salary we also offer a range of benefits including flexi time working, salary sacrifice pension scheme, membership of BUPA Healthcare, access to a Health Cash Back Plan with 24 hour EAP, annual profit share scheme, subsidised canteen and free on-site car parking.