Senior Bioprocess Associate MFG 7

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 Senior Bioprocess Associate MFG7you will be responsible for supporting and deliver on process and equipment operation activities during manufacturing operations. You will be expected to be a subject matter expert in Upstream and/or Downstream purification and in process analytical equipments. A key responsibility of this role will be to coach and mentor Bio-Processing Associates (BPA). Detailed knowledge of the process will be vital to ensure optimum process operations, as well as a high level of understanding of GDP. Department Description As Senior Bioprocess Associate MFG 7, you will 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 Bioprocess Shift Lead. Your Responsibilities In this role, you will provide co-ordination of scheduling activities and ensures all production supplies are available for day-to-day operations. Organise daily activities and work with BPAs in executing those activities in a safe, compliant, and efficient manner to maintain production schedules. Act as designee for the Shift Lead in their absence. Duties in this situation would include but is not limited to attending and chairing meetings, Bio-Processing Shift Lead holiday cover, use escalation process, act as a point of contact for BPAs during shift. Senior BPAs will perform all core production tasks in the areas of upstream and/or downstream and all ancillary tasks. Write, review and update of area Standard Operating Procedures (SOPs), On the Job Training (OJTs), Production Batch Records (PBRs), Logbooks, Training Competencies and Work Instructions. Carry out all production operations in the assigned area as directed by the relevant SOPs and Manufacturing Batch Records. Perform initial troubleshooting of issues identified during routine operations. Always adhere to Right First Time (RFT) principals. Assist where necessary with the training of colleagues in SOPs, process execution and equipment operation. Support the development of training matrices and ensuring compliance to training requirements. Escalation of any deviation from SOPs and batch records and provide assistance with investigation of deviations through the Trackwise system while using scientific, engineering, and lean principles. Lead and actively participate in shift handovers. Liaise with Shift Lead regarding issues which may arise from the production area including highlighting process bottlenecks. Where necessary assist in any facility, equipment start-up and validation activities. Provide input on equipment installation, operation and troubleshooting to support introduction of new products into sustaining operations. Work with cross functional teams to facilitate the development and validation of the Biologics manufacturing facility. Senior Bio-Process associates will also develop and demonstrate individual skills as subject matter experts and are required to display technical leadership by acting as Champion to drive improvements and excellence within specific aspects of the manufacturing operation within the shift team. Assist in driving and maintaining a safety orientated Culture, cGMP/GDP compliant work environment always. Liaise with other groups and individuals to ensure planning of tasks are effective and linked into the manufacturing process plan. Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Method 1, 2 etc.) to optimize efficiency and drive the culture of Continuous Improvement (CI) and Zero Defects. Support Equipment Design, HAZOP, and risk assessments as per requirements. Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g., Safety, Quality, Schedule delivery, EHS metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training. Provide assistance and/or support maintenance, engineering, quality, or other colleagues as requested. Due to the start-up nature of the project, there will be an expectation for flexibility and an ability to take on varied tasks at short notice not covered extensively within this

job description
. Conducts all activities that are in accordance with Company policies & SOPs, WuXi values, & global regulatory guidelines (including cGMP/cGLP/cGLP), environmental guidelines, as appropriate, e