Validation Specialist

Network Scientific Recruitment; England; Sur place; GBP 45 000 - 65 000; Plein temps

Résumé du poste

Network Scientific Recruitment seeks a Validation Engineer for a specialist life science client in the UK. You will lead validation activities in clean rooms, biocontainment and GMP environments, delivering protocols and related documentation.

You will coordinate with end users, designers and contractors, travel across the South of England, and contribute to continuous improvement while ensuring regulatory compliance.

Qualifications

• Scientific graduate and post-graduate qualifications in applied biology, biochemical/biomedical engineering.
• Understanding of SHE and regulatory requirements (GMP).
• Knowledge of GMP, GLP, biocontainment, and related pharma manufacturing standards.
• Membership of a relevant professional body.
• Familiar with cross contamination control strategies and quality risk assessments.
• Experience validating systems, equipment and environments.
• Experience delivering projects and coordinating stakeholders.
• Highly organized with attention to detail and confidentiality.
• Willingness to travel regularly.

Responsabilités

• Lead projects through all stages of design and development.
• Collaborate with end users, designers and contractors to meet timescales.
• Provide consultancy on clean room design, biocontainment and regulatory standards.
• Execute validation protocols at customer and vendor facilities.
• Generate quality risk assessments and validation documentation (URS, VMP, VP, RTM, DQ, IQ, OQ, VSR).
• Lead project meetings including site visits and progress reporting.
• Review and maintain project progress reports and budgets.
• Implement continuous improvement suggestions on processes and documentation.

Connaissances

Quality Risk assessments

Validation

Project delivery

Formation

Applied biology

Biochemical/biomedical engineering

Description du poste

Do you have validation engineering experience working in a GMP Life Science or Healthcare environment? Do you have expertise in clean rooms and biocontainment? Are you looking for an exciting and unique challenge with a rapidly growing business?

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.

Responsibilities will include

• 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
• Travel across the South of England and occasionally further afield - therefore need to be based in the South
• 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

To be considered for the role

• 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
• Knowledge of, GLP, GMP, biomedical, biocontainment, pharmaceutical manufacturing, or fumigation processes
• Understanding of cGMP Clean Rooms, cGMP related utilities maintenance, cGMP equipment engineering & maintenance, Validation, and warehousing for cGMP related materials /product storage.
• Familiarity with the RIBA stages of design.
• Willingness to travel on a regular basis

You will be rewarded with a friendly, inclusive working environment and competitive salary, as well as the opportunity to join a great business at an exciting time.

Please note that all applicants for this role should be able to prove that they are legally entitled to work in the UK.