Computer Systems Validation Specialist
Starting salary £42,230 DOE
Closing date 25th September 2020
Our client has approximately 400 staff, performing a range of process and analytical development, production, quality control and quality assurance roles associated with the development and manufacture of biopharmaceuticals. The department carries out the manufacture of Erwinase and Anthrax Vaccine, as well as contract manufacturing projects.
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.
This role is a hands-on position and requires the post holder to be able balance multiple project-based activities, coordinating the generation, review and execution of validation protocols with the relevant stake-holders.
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.
To minimize business risk associated with the processing and storage of electronic documentation ensuring continuity over the equipment and product's life cycle.
Main 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.
* Communicating validation activities with our internal and external customers and working with them to resolve problems and conflicts.
* In line with overall responsibilities, perform additional tasks assigned by the line manager.
* Undertake all work in accordance with Code of Safety Practice and site Quality Policies.
The successful candidate will have the following:
* 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.
* BSc in Engineering, Science or IT
* Experience of working with product Serialisation qualification
* Practical experience within a biopharmaceutical manufacturing environment.
* Practical experience dealing with internal and external audits, including regulatory agencies, inspectors and auditors.
* Understanding of the implementation risk in a site wide validation approach
* Critical assessment of reports and technical documents against customer and regulatory specifications and standards