▷ Urgent: MT Process Scientist

Company description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU, Asia and Israel. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies. Job description: The MT Process Scientist is a key member of the Manufacturing Technology team, responsible for ensuring that the process is running as intended, that it is appropriately validated and run so as to maintain that validated state. This role focuses on process monitoring, troubleshooting, including leading/supporting major process investigations at the request of business, implementation of cost reduction projects, facility and equipment design specification. A core function of the role will ensure on-going optimization of the manufacturing process from ideation to execution whilst providing day to day support to the manufacturing shift teams to ensure manufacture of product in accordance with schedule, ensuring a supply of high-quality biologic products meeting our company priorities. The scope of this role will also ensure the delivery of process excellence and reliability across all areas of the manufacturing process. The Process Scientist will also provide input to ensure the facility design meets end user requirements. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. Were one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing. Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. Department Description: As MT Process Scientist, youll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role youll be reporting directly to the Manufacturing Technology (MT) Lead. Essential Duties and Responsibilities include, but are not limited to: Interface with the project teams to ensure the manufacturing facility will operate as per the user requirements. Provide expertise in the design, commissioning and qualification of the new manufacturing facility at Dundalk through to commercialisation ensuring all necessary plans are executed and delivered on time. Provide technical knowledge in establishing the commercial process and routine manufacturing operations by serving as a commercial manufacturing process subject matter expert. Subject Matter Expert (SME) when trouble shooting process issues during start-up, tech transfer activities and commercial operations. S/he will work closely with the expanded manufacturing team ensuring any actions and plans are clearly accounted for and carried out in alignment of plant operations plans. Identify process improvement projects and implementation and work with the team to prioritise projects/support demands from the Business Unit. Write APQR and process impact assessments to support investigation closure as applicable. Implement process CAPAs and performance improvements, conduct investigation trending as required. Coach manufacturing personnel to increase technical knowledge of critical process steps and develops plans to build competencies and expertise. Participate in safety, process and environmental investigations. Reviews alert and action limits as needed and implement corrective action as appropriate. Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented. Change Control write up and close out. Participate in cross-functional project teams as applicable. Maintain role as Process Guardian. Responsible for analysis of routine statistical process control charts and follow-up of trends flagged. Support audit preparation. Introduction of new or alternate consumables or raw materials. Optimising re-use of filters and columns gels, sampling plans and consumable usage. Work to implement a culture of Right-First Time through partnerships with manufacturing shift teams and provide leadership in the use of Opex principles to optimise technical and business processes. Support the disposition process. Ensure all data ready in timely fashion in support of business unit disposition metric. Perform all duties in accordance with GMP requirements, SOPs and controlled documents Will be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Technology Lead. Will act as a role model for the Manufacturing function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Person Specification: Qualifications Third level qualification in a Science or Engineering related field. A postgraduate qualification in an engineering or science discipline would be advantageous. Knowledge & Experience: Thorough knowledge of current Good Manufacturing Practices (cGMP). Familiarity with Chromatography and Ultra filtration production operations is required. Computer Literacy. Minimum of 5 years experience in a large-scale Biopharmaceutical/pharmaceutical facility. Experience with facility start-up projects (brown field or green field) is desirable. Experience and knowledge of DeltaV MCS platform preferred. Familiarity with Chromatography and Ultra filtration production operations is desirable. Behavioural Competencies: Excellent communication skills including computer literacy. Ability to work independently and in a team. Excellent communication, interpersonal and presentation skills. Collaborative and inclusive approach to work and your colleagues. Experienced problem solving and troubleshooting skills. Flexible approach to work and a positive attitude will be a good fit within the team dynamic. Engage cross functionally in conjunction with a site-based team. Autonomous and a self-starter who will use their initiative to drive actions forward. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers expectations. Onerous requirements Must be willing to travel as required internationally to fulfil the responsibilities of the position. As we extend our global reach, we need colleagues interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential If you can thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our mission -Any drug can be made, and any disease can be treated- dont miss out on this opportunity to join us and reach beyond yourself and discover your true potential. Apply now Visit our website site: WuXi Biologics is an equal opportunities employer. Skills: Process Development Analytical MFG Process Benefits: Bonus Parking Pension VHI