Senior Bioprocess Associate MFG 7

WuXi Biologics; Leinster; On-site; EUR 90,000 - 115,000; Full time

Job summary

WuXi Biologics in Ireland seeks a Senior Bioprocess Associate MFG7 to support upstream and/or downstream manufacturing operations. You will act as a subject matter expert and mentor Bio-Processing Associates, ensuring GDP compliance and efficient process execution.

The role includes coordinating shift activities, maintaining production schedules, writing SOPs, and training staff. It requires experience in a cGMP/GDP environment and a strong background in bioprocessing with lean practices.

Qualifications

• Demonstrated experience in a cGMP/GDP environment.
• Strong knowledge in upstream or downstream processing.
• Experience with lean 6 Sigma tools (standard work, 5S).
• Experience operating automated control systems such as Delta V or Unicorn.

Responsibilities

• Coordinate scheduling and ensure production supplies are available.
• Organise daily activities and work with BPAs to meet production schedules.
• Act as designee for the Shift Lead during absence and chair meetings as needed.
• Perform core production tasks in upstream and/or downstream areas and related tasks.
• Write, review and update SOPs, OJT, PBRs, logbooks and training materials.
• Troubleshoot issues during routine operations and uphold Right First Time standards.
• Coach and train colleagues in SOPs and process execution.
• Escalate deviations and support investigations using Trackwise.

Skills

cGMP/GDP

Upstream processing

Downstream processing

Automation systems

Lean Six Sigma

SME

Shift coordination

Problem solving

Education

Science or chemical engineering degree

Tools

Delta V

Unicorn

Job description

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 equipment’s. 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 BPA's 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 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 update 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. 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, 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 and will typically require weekend working and periodic rotation between day and night shifts.
• Identify and manage equipment training gaps and requirements.
• 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 Bio-Processing Shift lead.
• Will act as a role model for the Manufacturing function and the wider organisation in adherence to the WuXi corporate core values and PROUD culture.

Education

• A degree in science or chemical engineering is preferred; or equivalent demonstrated experience in the biopharmaceutical industry as specified above

Knowledge/Experience

• Demonstrated experience of working in a cGMP/GDP environment
• Strong demonstrated knowledge in upstream or downstream processing is essential.
• Requires understanding of scientific principles, operational aspects of production equipment and automation control.
• Demonstrate experience as an SME in a biopharmaceutical operation.
• Experience in lean 6 Sigma tools in standard work and 5S are an advantage.
• Good level of knowledge and execution of validation protocols is an advantage.
• Experience of operating automated control systems such as Delta V, Unicorn or similar systems is desired.
• Demonstrated career progression is desirable.
• Previous experience acting as designee to the shift lead role is preferred.
• Experience in coordinating shift activities and escalation of issues to ensure all manufacturing processes are adhered to.

Personal skills

• Self-motivated with excellent communication and interpersonal skills
• High level of adaptability working in a fast-paced environment and champion change
• Ability to positively influence and work well with others.
• Show leadership and support to junior team members.
• Ability to troubleshoot and strong analytical skills.
• Comfortable making risk-based decisions.
• Results driven and a proven record of being a high achiever.

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!

WuXi Biologics is an equal opportunities employer.