Senior Process Engineer Upstream/Downstream MFG

Senior Process Engineer MFG 7 Upstream or Downstream Reporting to the Manufacturing Technology Lead, the Senior Process Engineer will play a pivotal role in establishing the Manufacturing Technology team, with responsibility for providing engineering support to the ongoing

for MFG 7 UPS or DPS, as well as supporting any future tech transfer projects into MFG 7. Organization Description WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re 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. 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 Senior Process Engineer MFG 7, you’ll 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 you’ll be reporting to the MFG Technology Lead. Your Responsibilities Essential duties and responsibilities of this role include and are not limited to the following; Assist in site start up and project related activities: Support package owners on vendor management and equipment or process related activities and queries. Generate equipment verification & validation protocols and reports as required. Review vendor documentation for completeness and accuracy. Participate in FAT and vendor related activities. Support issue resolution during equipment installation, commissioning and qualification phases. Participate/Execute/Lead verification & validation related activities as required. Support CQV execution team as needed. Ensure equipment is designed and tested to meet the requirements of the process, to ensure that the equipment continues to run as intended, that it is appropriately validated and maintained in that validated state. Coordinate the delivery of a robust process and reliable equipment in support of a Right First Time Operating Unit. Main point for communications with the Core Engineering group for MFG 7. Implement equipment CAPA’s and performance improvements Execute and lead equipment verification, validation & revalidation protocols as required. Provide equipment technical support and troubleshooting. Provide routine Automation support, troubleshooting and maintenance. Champion and drive the implementation of Global Requirement Program tools and techniques within the Operation Unit. (for e.g. Operator Care, PdM, PMO, Work Management) Drive the use of PI to provide business efficiency Identify equipment improvement projects for Core Engineering Unit. Work with the portfolio management process to identify projects/support demands from the Core Units. Champion and Support Energy saving programs/projects within the Operating Unit. Write equipment assessments to support investigation closure. Conduct Investigation Trending. Change Control write up and close out. Lead / provide SME input into cross-functional teams investigating manufacturing process, environmental and water monitoring deviations including authoring investigation reports, technical assessments and summaries. Ensure investigations are closed on time, recurring deviations are tracked, and that true root cause and effective CAPA are identified and implemented. Participate in cross-functional project teams as applicable. Provide input and work with the MFG leadership team to deliver the MFG objectives. Support audit preparation. Coach manufacturing team on OpEx tools and use OE systems as the basis for identifying improvements. Implement and support continuous improvements that reduce cycle times and operational costs. Coach production personnel in manufacturing equipment as required. Developing and maintaining a database for investigations, or other required department tracking and data analysis needs, as applicable. Complete biennial review and PQS updates. Support the disposition process. Ensure all data ready in timely fashion in support of Opu 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. Your Profile: The ideal candidate for this position will have the following: Qualifications: Third level qualification in a Science or Engineering related subject is preferable. Knowledge/Experience: Minimum of 8 years’ experience in a large-scale in a Biopharmaceutical/pharmaceutical facility. Ideally, experienced in establishing a Manufacturing Technology team in a ‘greenfield’ context of similar size and scale. Excellent communication skills including computer literacy and ability to work independently and in a team. Thorough knowledge of current Good Manufacturing Practices (cGMP). Experience and knowledge of DeltaV MCS platform preferred. Familiarity with Chromatography and Ultra filtration production operations is desired. Behavioural Competencies Strong leadership competencies with demonstrated management skills. Excellent communication skills including computer literacy and ability to work independently and in team. Strong leadership competencies with demonstrated management skills. Ability to think critically and demonstrate troubleshooting and problem-solving skills. Self-starter and self-motivated; organized with good attention to detail. Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities. Results oriented, with the ability to manage multiple priorities in a short period of time. Collaborative and inclusive approach to work and colleagues. Engage cross functionally in conjunction with a site-based team. Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectations. Other 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! Apply now! Would you like to know more before you apply? Please visit us at [外部招聘链接已隐藏] or contact us via talentacquisition@wuxibiologics.com WuXi Biologics is an equal opportunities employer.