Senior Csv Specialist - Sawston, United Kingdom - AdventBio

AdventBio
AdventBio
Verified Company
Sawston, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
We are currently seeking a highly experienced and dedicated Senior Validation Specialist to join our Validation team.

Company Information


Advent Bioservices is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services.

We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using advanced therapy medicinal products.

Job Summary


Based in Sawston, the Senior CSV Specialist will be experienced in computer systems validation activities associated with equipment, facilities and laboratory systems.


The post holder will be responsible for independently leading projects, coordinating personnel and processes to ensure that projects are delivered on time and produce the desired results.

The post holder will be the SME for their projects and provide support to other stakeholders.


The Role will primarily be focused on the onboarding validation of new Computerised Systems to meet the demands of an expanding customer base, as well as supporting the ongoing validation requirements of the expanding Software Systems.

The Role will work closely with IT to define Data Integrity requirements and assess the efficacy of implemented solutions.


Key responsibilities will include:

  • Lead independent validation project execution in conjunction with relevant stakeholders ensuring timelines and deliverables are achieved
  • Document peer review, system audits and business analysis for system configuration and URS generation.
  • Managing requalification of systems and equipment
  • Supervising validation testing performed by vendors to ensure work is complete and accurate
  • Supporting the implementation of a riskbased approach to the validation of systems to ensure compliance with Annex 11, 15 and industrial guidance such as GAMP 5 guidelines, along with company quality documents and guidelines.
  • Preparing and maintaining validation plans, assisting system owners with impact assessments, risk assessments and identifying validation requirements for equipment, facility and systems projects.
  • Preparing and executing validation protocols for equipment, facilities, utilities, computerised systems, and processes. Including aspects of system security and electronic signatures in accordance with Annex 11/Part 11 and Data Integrity guidance.
  • Demonstrable experience of validating computer systems, including the generation/execution of lifecycle documents in a biopharmaceutical, or related industry, to the required quality and regulatory standards
  • Experience of successful interfacing with multifunctional project teams and external contracted resources to develop requirements, establish programs and complete the validation
  • Knowledge and understanding of how to implement the Good Automated Manufacturing Processes guidance
  • Experience in the validation of GxP Software Systems
  • Experience in the validation of GxP Computerised Laboratory Systems
  • A Degree (or equivalent experience) in a Science or related discipline
The is a fantastic opportunity to join a growing organisation. We offer an attractive base salary and benefits package.
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