This role will be part of the Manufacturing Self Directed work team/ Hub in the new state-of-the-art single-use multi-product biotech facility in County Meath, Ireland. The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists. The Lead Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and collaboration skills. The Lead Manufacturing Biotech Associate is responsible for supporting the manufacturing process while creating an inclusive culture that energizes Safety First, Quality Always, with a continuous improvement mindset. Ensure that objectives are effectively achieved, and consistent with the company requirements to ensure compliance, and safety and provide a reliable supply to our customers.
• Carry out and support operations to achieve assigned duties.
• Deliver shift standard work for a team-based approach to batch progression.
• Complete COMMIT cards to highlight ways of working within our SDWTs and Hubs and across our site that support our COMMIT culture.
• Conduct sampling/ in-process testing supporting the manufacturing and validation processes.
• Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT).
• Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance with cGMP requirements.
• Provide coaching to the shift teams on the RFT approach to documentation.
• Ensure that all assigned tasks related to manufacturing documentation support are in accordance with good manufacturing practices.
• Initiate/ maintain housekeeping in all work areas.
• Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate.
• Support execution of safety walk-downs, audits/ inspections, risk assessment, implementation of agreed-upon actions, etc.
• Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as and when required.
• Coach and provide oversight on the shop floor to identify potential issues before they arise.
• Actively participate in cross-functional manufacturing teams to advance projects, goals, and deliverables.
• Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
• Lead straight-through document accuracy metrics and the development of a CI framework.
• Support site functional initiatives to improve compliance status and operational efficiency of the site.
• Run handover boards and provide key updates to shift leads for handover.
• Be the escalation point of contact (POC) for troubleshooting, supporting task execution & problem-solving.
• CI projects and assist with the resolution of issues/ delays.
• Take ownership of activities within a suite and act as a delegate for the shift lead if they are unavailable.
• Ensure process equipment is maintained including preventative maintenance, equipment troubleshooting, and repairs to ensure continuous, reliable, and repeatable operation of equipment.
• Effectively manage and schedule equipment shutdowns.
• Ensure resources are available, thereby minimizing downtime.
• Minimum of a Bachelor’s Level 8 degree in Science, Engineering, or other Technical Discipline.
• 5 years of experience in a GMP environment.
• 3 years of experience in the Biopharma industry, with direct experience in biologics manufacture.
• Proven record of accomplishments in a regulated industry is required.
• Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and implementation of Good Manufacturing Practices.
• Ability to effectively coach new trainees to build their skills so that they may become effective operations technicians and subject matter experts.
• Ability to think logically and be proactive under pressure.
• Excellent troubleshooting and problem-solving skills to coach and mentor the teams through complex problems solving.
• On-the-floor current Good Manufacturing Practice (cGMP) manufacturing and familiarity with regulatory requirements.
• Proficiency with automated systems such as Manufacturing Execution Systems (MES – PAS X).
• Systems Applications and Products (SAP), Delta V, etc.
• Knowledge of Lean methodologies.
• Familiar with all Safety, GMP, Environmental, and Validation permits, policies, and procedures.
• Familiar with plant equipment.
• Training others and/ or leading hands-on or instructor-led training.
• Ability to read, write and understand technical information.
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