▷ Immediate Start CQV Engineer

3 weeks ago

Dundalk, Ireland WuXi Biologics Ireland Limited Full time

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: As CQV Engineer (Thermal Mapping)you will be responsible forthermal mapping activities for the upstream and downstream packages to enable start-up of the processing facility and for the ongoing activities during sustaining operations. The Thermal Mapping Specialist is responsible for ensuring that all manufacturing and Warehouse processes and QC systems perform and operate as per their design. The Thermal Mapping Specialist ensures that all systems conform to relevant regulatory requirements as well as company specifications and standards. Organisation 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. We have sites/offices in China, the US, the EU, Asia, and Israel. We currently employ over 10,000 people and provide services to more than 200 customers worldwide, including 13 of the top 20 biopharmaceutical companies. Department Description AsCQV Engineer (Thermal Mapping) youll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives.In this role you will be reporting to the Thermal Systems Validation Lead. Your Responsibilities In this role, youwillReview Protocols / Reports for Equipment Commissioning & Qualification activities on-site, including URS, Risk Assessments, DQ, FAT, SAT, IOQ, PQ. Co-ordinate/ perform all temperature mapping and validation of equipment such as fridges, freezers, autoclaves, incubators, stability cabinets and SIP systems. Maintain SOPs / WIs associated with Qualification & Validation studies. Ensure Project related work is carried out in accordance with the requirements of Validation Policies, Guidelines, Site Validation Master Plan and GMP. Sterilization / sanitization validations site-wide, as required. Temperature distribution studies site wide, as required. Co-ordinate / perform other Performance Qualification and Re-qualification / Re-Validation studies, as relevant. Generation of reports / analysis of data against pre-determined criteria to GMP standards. 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 Thermal Systems Validation Lead Will act as a role model for the Engineering function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture. Your Profile The ideal candidate for this position, will have the following: Education A degree in a life-science / engineering related discipline is required. Knowledge/Experience Required: Minimum of 3 years experience in thermal mapping. A good understanding of the bio-pharmaceutical industry including GMP and relevant validation requirements. Personal skills Excellent communication, interpersonal and presentation skills. Collaborative and inclusive approach to work and your colleagues. Excellent 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. Drive a Continuous Improvement Culture within the Engineering team. 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 have the ability to 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 Would you like to know more before you apply? Please visit us at WuXi Biologics is an equal opportunities employer. Skills: GMP Thermal mapping CQV Benefits: Bonus Pension Sports & Social Club VHI

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