Fresenius Kabi is a global healthcare company that specialises in lifesaving medicines and technologies. Our product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products.
The Fresenius Group employs over 350,000 high-calibre professionals across the world, with a workforce of circa. 1,000 within Fresenius Kabi across the UK and Ireland.
The role
We're looking for an experienced CSV Engineer with proven experience in a Pharmaceutical, Life Sciences or similar industry to join our Aseptic Services department. The CSV Engineer would assist in the coordination of company’s computer systems validation projects. They will have an opportunity to work with internal and external parties to produce high quality solutions to critical business and regulatory requirements. The role is 37.5 hours per week Monday - Friday.
Key responsibilities
* Work with the relevant Change Owner for all GxP IT systems, including risk identification and mitigation, responsible for tracking changes through to completion
* Prepare and execute 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 and process owners to maintain the compliance of IT and software systems throughout the lifecycle
* Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new software projects throughout the project lifecycle, including updating the dynamic validation master plan
* 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
* Proven experience in a Pharmaceutical, Life Science or similar environment
* 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 and an understanding of IT Qualification activities would be beneficial
* No rota'd weekend working and no night shift
* Contributory Pension Scheme (rises with service)
* Role specific tailored training and development plan
* Life Insurance (4 x salary, death in service)
* 33 days holiday (rises to 35 after 5 years service) and ability to buy/sell holidays
* Healthcare cashback scheme (including dental, optical & alternative therapies)
* Maternity, Paternity and Adoption Leave
* Bike to work scheme
* Long Service Awards
* Employee Assistance Programme
* Free onsite parking and subsidised canteen
* Blue Light Card
* Company funded family days out
We are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.
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