Job Description
PE Global is currently recruiting for a Lead Biotech Associate for a leading multi-national Biotech client based in Meath. This is an initial 11-month contract shift position in a new state of the art single use multi-product biotech facility. 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 in a new state of the art single use multi-product biotech facility. ROLE: Carry out and support operations to achieve assigned duties. Deliver shift standard work for a team-based approach to batch progression. 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. REQUIREMENTS: Minimum of a 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 industry experience . 5 years experience in a GMP environment. 3 years experience in Biopharma industry, with direct experience of biologics manufacture. Proven record of accomplishments in a regulated industry required Interested candidates should submit an updated CV. Please click the link below to apply, call Sen on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: GMP Biotech Manufacturing