Fujifilm Diosynth Biotechnologies is investing £400M to introduce a new, state-of-the-art biomanufacturing facility. This biomanufacturing facility will provide additional Cell Culture cGMP manufacturing capacity to the existing Billingham, UK campus and is expected to become operational in 2025. For Project Borealis, there are 2 phases to the role; in phase 1 the successful applicant will join the project team and contribute to the set up of the facility, participating in preparation activities to ensure Borealis is operationally ready for December 2025. We are a dynamic global company and our focus is to combine technical leadership in cell culture, microbial fermentation and gene therapies with world class cGMP manufacturing facilities to advance tomorrow’s medicines. With sites in Billingham & Wilton UK, Hillerod Denmark, North Carolina and Texas USA, the size and breadth of our business will open up huge opportunities for you, whether you want to move to a different role in the UK, relocate, or progress and take on more responsibility. Our teams are proud to partner with innovative companies reimagining what’s possible in biopharmaceuticals. Every day at FDB is a day for improvement, each challenge is an opportunity for growth, and every moment is a chance to evolve together. Adhere to relevant EHS and GMP standards. The job holder will lead by example and demonstrate the ability to challenge and change unacceptable practices to continually improve ways of working in manufacturing. Has extensive knowledge of the biologics manufacturing process and operation of associated production equipment. Ensures all products introduced into GMP manufacturing assets are assessed for cleanability and undergo recovery studies. Responsible for authoring and or approving cleaning validation protocols and reports and supports cleaning validation campaigns. Responsible for authoring Quality Risk Management Protocols and Reports. Provides support to manufacturing with respect to any investigations linked to cleaning and or contamination control. Trend cleaning data to monitor trends or factor changes. Interacts with customers and regulatory agency personnel during visits and audits. Grade C or above in GCSE English and Maths Higher education (or apprenticeship) in a relevant science / process related subject A minimum of three years’ experience working in a GMP environment Knowledge of biologics manufacturing Experience of authoring and / or reviewing GMP documentation Understanding of cleaning validation and cleaning philosophies e.g CIP/SIP Root cause analysis trained At FDB, your passion – your Genki – is your power and we empower you to define what Genki means to you. When you join us, we will train, develop and support you to become the best you can possibly be. We offer a structured new starter induction programme as well as on-going development training. In addition to this, we offer: Competitive salary plus company bonus scheme 35 days of holiday, plus bank holidays. Salary Sacrifice scheme offering, healthcare, bikes, dental etc. Generous pension scheme Free parking and electric charging points Closing date 20th November 2024 Systems Technologist JD Systems Technologist PS