RHL has a long-standing relationship with a leading UK based biopharma manufacturing company, which focus on unique life-saving vaccination products. Based on ongoing expansion they are recruiting for a Computer System Validation (CSV) Specialist to join their rapidly growing, stable team. Since being established in 2015, the company has doubled in size and is now looking for a CSV Engineer with experience in a pharma environment. They are riding a wave of success based on their completely innovative vaccines which are in high demand, and are looking to move forward to the next phase of the companies development.
The Validation team comprises of approximately 30 specialists on a permanent or contractual basis. The scope of Validation activities for the team covers general re-qualification of equipment, facilities and utilities with an experienced knowledge base of Computer System Validation, Cleaning Validation, Process Validation and the delivery of capital equipment into beneficial use.
This role within the Validation team is necessary to manage and execute validation activities associated with the cGMP compliance of computerised and software systems, ensuring that they are appropriately qualified and fit for operational use.
The role will ensure that the commercial risks associated with disaster recovery and data life cycle compatibility are addressed for each computer system guaranteeing long term availability of business-critical systems and data.
In addition, this role will have an input into CAPEX projects where there is a significant computerised / software content, ensuring that systems have been appropriately designed and qualified to ensure effective and cGMP compliant operational use.
To lead and execute CSV validation activities of computerised systems and associated equipment in accordance with current regulatory requirements.
The post holder will have the following duties and responsibilities;
Take the lead in computer system validation and compliance, manage and deliver specific Validation Projects according to the business priorities, including work scheduling and supervision of junior members of staff.
Comfortable working alone or within the matrix management system.
Continuous improvement of validation systems and procedures to ensure efficiency and best practice within the industry and to stay abreast of changing regulatory expectations.
Write, review and approve validation documentation including protocols and reports and manage the timely closure of any discrepancies or non-conformities.
Providing a reliable service to our internal customers to ensure that timescales are met and work is carried out to meet expectations.
Maintaining the ongoing compliant status of computer systems associated with equipment, facilities and utilities by involvement of the scheduling of activities
General education to BTEC National Certificate or equivalent, including science.
Substantial experience of generation, execution and review of validation protocols, reports and technical documents.
Experience of validation life cycle activities for computerised systems.
Substantial practical experience of working within a GMP quality system.
Experience of dealing with internal customers, identifying and delivering work programs, reporting progress and dealing with issues.
A comprehensive understanding of EU and FDA regulatory requirements relating to validation including (but not limited to) UK/EU GMP Annex 11 and 21 CFR Part11.
An understanding of GAMP processes.
Technical understanding of computerised systems including PLCs, SCADA, networked systems, laboratory systems, databases, layered software as used in a GxP environment.
If you feel you could be a fit for this role please apply below