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Our client are a specialist life science and healthcare company who work with a range of clients including universities, pharmaceutical manufacturers and the NHS. They provide expert advice and knowledge in relation to clean room environments, biocontainment and laboratory set-up, providing a high level of service in order to support their clients achieve their goals with relation to establishing new laboratories and expanding existing ones. Due to growth, they are now looking to recruit a Validation Engineer to join their team.
Job Responsibility:
Lead Projects through all stages of design and development
Working with a project team of end users, designers and contractors to deliver high quality projects to timescale
Provide detailed consultancy to project stakeholders in line with regulatory and engineering standards for clean room design and construction
Execution of validation protocols at customer and vendor facilities
Generation of Quality Risk assessments
Lead project meetings including site visits
Generation of Validation Protocols for a full validation life cycle
Producing documentation specific to customer requirements: URS, VMP VP, RTM, DQ, IQ, OQ, & VSR
Responsible for the review, creation and maintenance of project progress reports including internal reports on project progress against budget and costs
Implement continuous improvement suggestions on process, procedures and documentation
Requirements:
Scientific graduate and post-graduate qualifications in applied biology, biochemical/biomedical engineering
Understanding of SHE, ensuring compliance with regulatory and legislative requirements
Good understanding of research & pharmaceutical manufacturing regulations – GMP
Membership of relevant professional body
Familiar with Cross contamination control strategies & Quality Risk assessments
Experience in the validation of systems, equipment, and environment
Experience of project delivery
Highly organised and methodical with attention to detail
Able to maintain confidentiality of Company and clients’ information
Experience of working in a Clean Room or Laboratory environment
Understanding of cGMP Clean Rooms, cGMP related utilities maintenance, cGMP equipment engineering & maintenance, Validation, and warehousing for cGMP related materials /product storage