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CSV Engineer /contract-w2

Salary undisclosed
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Computer Systems Validation Specialist Job Description
2465_Computer Systems Validation Specialist Job Description
Role Purpose:
Reporting to the Validation Manager within the Operations team, the Computer Systems Validation
(CSV) Specialist will be responsible for computer systems validation activities at the new CPI MMIC
Facility, located just outside Glasgow, and will have the skill set and experience to be able to make
an immediate impact. The specialist will contribute to the development, execution, and continued
optimisation of the MMIC s CSV guidelines and procedures, which will underpin the validation of the
facilities various software systems and their ongoing connectivity. The role is key to ensuring the
compliance of the facility s quality, manufacturing, and engineering systems with current GxP and
GAMP5 requirements.
The first priority for this new role will be the validation of a new filling line, covering the qualification
of the SCADA, MES, Dashboarding and Scheduling systems of this integrated automated tablet and
capsule filling system. In addition, there will be the requirement to oversee the further integration
of these systems with the facility s EMS and QMS systems and their validation, and an ongoing
responsibility for qualification of all hardware and software systems as they come on board.
Responsibilities:
To maintain consistent and documented compliance with all relevant Safety, Health and
Environmental (SHE), Good Manufacturing Practice (GMP), Data Integrity (DI), quality and
best practice requirements.
To identify and document computer systems which impact upon GxP and aid in the
performance of the validation of identified systems at the MMIC facility in Glasgow.
To quickly gain a detailed understanding of current CPI and vendor validation strategies
and documentation packages for the validation of Grand Challenge projects currently
ongoing.
Hold expertise in validation procedures and performance in line with GAMP5 guidance

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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