Computer Systems Validation Specialist

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Job Details

Glasgow Home Based
Up to £50,000 per annum depending on experience
Full-time - Permanent
Medicines Manufacturing Innovation Centre
06 Dec 2020 - 00:00
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CPI in a nutshell

At CPI we work with our partners to translate inventions into products and processes that enhance health and well-being, protect and improve our environment and increase productivity across industries.

With a deep understanding of innovation processes and funding, outstanding technical expertise and industry relevant assets, we enable products and processes to be quickly and cost-effectively brought to market. This supports the development of next-generation manufacturing, highly-skilled jobs and economic growth for the UK.

Our partners operate across many diverse markets including pharmaceuticals, speciality chemicals, food and drink, electronics and transportation.

Why this role is important for CPI’s work

CPI is offering a new and exciting opportunity to be part of our Medicines Manufacturing Business Unit as a Computer Systems Validation Specialist. This new role represents substantial company growth and an exciting phase of transformation as the team continues to expand. You will be responsible for the validation of IT Infrastructure for the new CPI MMIC Facility based in Glasgow. In particular this role will have a focus on the cover the validation oversight of SCADA, MES, Dashboarding and Scheduling applications and their integration with each other. 

Duties include:

- To ensure the interaction between IT systems is included in vendor validation.

- To witness FAT and SAT tests, where possible.

- To manage the validation full lifecycle of the MMIC software systems ensuring that they operate in compliance with cGMP/​GAMP5 requirements.

- To author and support others in the generation of the lifecycle CSV deliverables for each computer system e.g. validation plans, summary reports, configuration specifications and change control.

- To maintain appropriate validation documentation and files according to cGMP and CPI validation policies and procedures.

- To maintain the CSV schedule to ensure all quality, manufacturing and engineering systems remain qualified to current GMP / GAMP 5 requirements.

- To act as change owner for all digitally-connected GxP systems within the facility tracking changes through to completion and risk identification and mitigation plans.

- To proactively support line management and the rest of the management team in the execution of their responsibilities.

- To provide regular, accurate and timely reporting of progress to the project sponsors and stakeholders.

- To take the lead during internal and external audits of the CSV lifecycle plans and validation documentation. 

The person we are seeking

We are looking for an experienced, self-motivated individual who can hit the ground running. It is essential you are Educated to Degree Level (or equivalent) in an IT / Infrastructure Management subject. You must also have experience of operating at an expert level in CSV. Further, you must have extensive knowledge of GAMP, GMP Guidelines EU GMP Annex 11 and Annex 15, 21 CFR Part 11. Evidence of experience of providing support for internal and external audits is also essential. Ideally the successful candidate will have experience managing collaborative R&D / Development technical transfers. 

What does CPI offer you?

At CPI, we offer a wide range of benefits to our employees, this includes:

  • Up to 33 days holiday, including bank holidays – Plus a holiday purchasing scheme
  • Generous pension scheme
  • Life assurance and accident insurance schemes
  • Flexible working
  • Learning and Development Opportunities
  • Free parking

Find out more about our culture and benefits.

Additional information

All applicants must have the legal right to live and work in the UK at the time of application. Presentation of appropriate original documents will be required.

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