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Next Phase Recruitment
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Stevenage, Hertfordshire
Engineering Project Manager - GMP
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Job Type: Full-time |
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Overview
A cutting-edge biotech is recruiting for an Engineering Project Manager to join a state of the art Cell & Gene Manufacturing Centre based in Stevenage. The company are a leading the way in the commercialisation of cutting-edge therapies that are now advancing through the clinical trial phases that are manufactured at their Stevenage site. They are recruiting for someone to join their team who can coordinate all company, collaborator and contractor activities in the centre for both hard and soft services. There are two roles available due to the centre having recently been expanded and the need to meet the requirements of collaborators. The Role : The purpose of the Engineering Project Manager is to support the relationships with collaborators through the modification and maintenance of the facility. The type of projects ranges from the setup of new clean room areas, continuous improvements and the on-boarding of collaborators into the site for example. The Engineering PM will manage projects throughout their life-cycle taking these from the planning stages to completion covering both hard and soft services. Developing business cases to support capital project proposals including project initiation and Cap – Ex requests to gain business approval and funding. To develop project cost estimates that are communicated to stakeholders and managed throughout the project. You will define monitor and maintain project programs through design, construction, commissioning and validation phases in line with time-lines. Taking a proactive approach to the management of the projects to ensure these are delivered. As the Engineering Project manager you will also be responsible for the compliance of the projects and ownership of risk assessments, HAZOPS and HAZIDS, contractors etc This is an excellent opportunity to be involved in a range of projects in a state of the art facility in an influential role where you can grow with the role and develop your career. Experience : You will need to have experience of working in GMP environment, preferably within a biologic, bio pharmaceutical, ATMP, cell / gene therapy, or pharmaceutical manufacture. With proven engineering experience for hard and / or soft services, with the ability to manage projects in a similar environment with a degree in life science, engineering or related discipline. The Company: The company are a centre of excellence that is at the forefront of creating a viable and sustainable cell and gene therapy industry. Their headquarters are in central London where they have built a leading multidisciplinary team that has the ability to take a therapy from concept through the development cycle to the market. They collaborate with both academia and industry and they are able to provide the scientific, clinical and commercial expertise needed to overcome the challenges that hinder the commercialisation of these fast developing, cutting edge technologies. They have constructed a purpose-built manufacturing centre which opened at the end of 2017 and immediately after opening additional funding was allocated for the centre to be doubled in size due to the demand for their services. This currently consists of 12 (recently completed) clean room suites out for collaborators to use to manufacture advanced therapies for use in clinical trials.