Job Description
This is an 11-month initial contract. It is an onsite position and a 24/7 shift position, Purpose 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 Dunboyne, 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 a Safety First, Quality Always, with a continuous improvement mindset. Ensure that objectives are effectively achieved, consistent with Company requirements to ensure compliance, safety and provide a reliable supply to our customers. Responsibilities 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 is 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 walkdowns, 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 on 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 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. Any other duties as and when assigned by the Manager. Such as act as a designee for Manufacturing Shift Lead as required. Requirements Bachelors Level 8 degree in science, engineering or other technical discipline, or a Level 7 qualification in a science or engineering discipline with a minimum of 5 years experience in a GMP regulated environment. 5 years experience in a regulated GMP environment. 3 years experience in Biopharma industry, with direct experience of biologics manufacture would be desirable. Proven record of accomplishments in a regulated industry required. This role is a site based position. This role will involve working shift, on a 24/7 basis. 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 trouble shooting and problem-solving skills to coach and mentor the teams through complex problems solving. Proficiency with automated systems such as Manufacturing Execution System (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. Skills: Operations Support Right First Time Level 8 Degree MES SAP GMP