C&Q Engineer - Cleanroom/HVAC (9 Month Contract)

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Company Description The Vaccines Manufacturing and Innovation Centre (VMIC) has been established to provide the UK's first strategic vaccine development and advanced manufacturing capability. VMIC will fast track development and manufacture of early-stage vaccine products, as well as serve as the UK's response capability to produce vaccines against emerging infectious diseases. They have already taken a leading role in the Government's national response to COVID-19.New starters can expect to join an exciting fast-paced organisation, with ambitious growth plans. With a flat structure, employees will have exposure to senior leaders and be part of an organisation that has a start-up mentality but is backed by the UK Government, and industry and academic founders.Working through collaborative ventures with industry, academia and NGOs, VMIC will ultimately strengthen and innovate the UK's vaccines sector. Their state-of-the-art vaccines manufacturing facility will be located on the renowned Harwell Science and Innovation Campus near Didcot in Oxfordshire. Job Description

The role involves with the working with C&Q Lead & CQV Manager to define and implement the C&Q strategy for production/laboratory equipment, facilities, and utilities on the VMIC Facility in Harwell Oxfordshire. This will be achieved through the preparation and execution of high-quality C&Q documentation. The role also involves training and mentoring C&Q team members in risk-based approach C&Q approach. Assist C&Q Lead in preparation/update of C&Q standard operating procedures.Participate as C&Q SME to the URS preparation process.Review and approve supplier factory acceptance tests and site acceptance test plans/protocols for Cleanroom/HVAC systems.Witness the execution of factory acceptance tests and site acceptance test plans/protocols for Cleanroom/HVAC systems.Prepare risk assessments, traceability matrix and C&Q protocols (DQ/IQ/OQ/PQ) for Cleanroom/HVAC systems.Co-ordinate review and approval of risk assessments, design specification and functional specification, traceability matrix and C&Q protocols (DQ/IQ/OQ/PQ) for Cleanroom/HVAC systems.Execute C&Q protocols (DQ/IQ/OQ/PQ) and prepare C&Q summary reports.Assist C&Q Lead in Maintain the qualification status of production/laboratory equipment, facilities, and utilities systems according to a predefined frequency and in accordance with current internal SOPs.Contribute to ensure that changes introduced in the organization of quality systems, procedures and processes are managed so that all aspects of the equipment, facilities and utilities systems commissioning and qualification process are assessed and accordingly performed. Personal Specification You will be a flexible, highly motivated quality professional seeking opportunities to develop and grow your skills within a fast-moving leading-edge organization. You will have extensive experience of the Pharmaceutical industry (and particularly vaccines) with a thorough understanding of current GMP and relevant technical processes. You will be able to demonstrate: Minimum Degree qualification in a relevant scientific disciplineSubstantial experience working in [5-10 years], preferably with biologics and sterile manufacturing site experience.Excellent scientific and technical knowledgeKnowledge of current GMP standards and guidelines related to equipment, utilities and facilities qualification (e.g. ISO, ICH, FDA, ISPE)Knowledge of the necessary qualification and validation steps and tools (FMEA, RA, URS, DQ, IQ, OQ, PQ) * Detailed knowledge of GMP requirements and their technical implementation in clean room classes A to D (EUGMP)Knowledge of Good Engineering Practices (GEP)Practical experience in the technical support of sterile production areas, as a plant engineer, project managerProactive, open personality that recognizes Production, Quality and Engineering Departments as internal customersCollaborative team member with excellent communication skillsIT skills - Windows Professional Office and Microsoft Office applications

Equal Opportunities VMIC is proud to be an equal opportunity employer. We welcome applications from all individuals regardless of race, national origin, gender, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any other protected characteristic. We are committed to treating all applicants fairly and without discrimination.Please click here to find out more about our Key Information Documents. Please note that the documents provided contain generic information. If we are successful in finding you an assignment, you will receive a Key Information Document which will be specific to the vendor set-up you have chosen and your placement.To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales