The primary responsibility of this role will be to support and deliver on process and equipment operation activities during manufacturing operations.
As a Senior Bio-Process Associate, you will be expected to be a subject matter expert in Upstream and/or Downstream purification and analytical techniques. 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.
Essential Duties and Responsibilities
• Provides co-ordination of scheduling activities and ensures all production supplies are available for day-to-day operations.
• Organise daily functions and work with BPA’s in executing those functions 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 BPA’s during shift.
• Senior BPA’s will perform all core production tasks in the areas of upstream and/or downstream and all ancillary tasks.
• Write, review and revision of area Standard Operating Procedures (SOPs), On the Job Training (OJT’s), 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. Adhere to Right First Time (RFT) principals at all times.
• 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 at all times.
• 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 Equipement 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/cGCP), environmental guidelines, as appropriate, etc. Advise management of non-conformance issues and opportunities for (CI).
• Shift working is required. The shift pattern may be varied according to business requirements