Biotech AssociateThe BTA plays a critical role in supporting safe, compliant, and efficient biologics manufacturing. They execute automated, paperless manufacturing processes across cell culture, filtration, and purification activities using state-of-the-art single-use technology. Working on a designated shift, they set up equipment, run production operations to world-class GMP and EHS standards, and contribute to continuous improvement through standard work and lean practices. This role is central to delivering high-quality drug substance to patients.Responsibilities:Support operations team to consistently deliver on specific Key Performance Indicators (KPIs), e.g. Environmental Health and Safety (EHS) metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training.Complete COMMIT cards to highlight ways of working within our SDWT's and Hubs and across our site that support our COMMIT culture.Provide immediate feedback to others at any time to reinforce good safety and improvement behaviours and acts.Execute commercial manufacturing processes according to established work instructions and Standard Operating Procedures (SOPs).Ensures that all assigned task related to manufacturing documentation support is in accordance with good manufacturing practices.Routinely talk about any safety issues you are concerned about.Work as part of a dedicated proess team where flexibility and teamwork are a key requirement.Generate SOPs/ Work Instructions (WIs) to ensure compliance with regulatory standards.Provide assistance and/or support maintenance, engineering, quality or other colleagues as requested.Escalate issues as appropriate to manager/designee.Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan and site schedule.Challenge and identify improvements to the safety and environmental programmes on site.Celebrate with use of proactive recognition tools that inspire teams and individuals you collaborate with.Take part in shift handovers and tier 1 meetings, raising concerns or issues promptly and providing options for resolutions.Act as an ERT during emergency situation if trained .Maintain/ support a high standard of safety/ Good Manufacturing Practice (GMP) compliance at all times.Determine solutions by referencing relevant past experiences as part of problem solving activities.Get actively involved by participating in inspections, GEMBA's and Go-See's.Act as a team member on process deviation reviews and Gemba walkdowns.Be prepared to answer auditor questions during site walkdowns.Engage in implementing innovative solutions that drive a high performance organisational culture that accommodates rapid growth and highly dynamic expectations ensuring attainment of site operational and development goals.Utilize Lean Six Sigma Tools to support the initiative of continuous improvement (CI) projects to increase agility, flow, throughout and reduce cycle time and inventory.Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organizations throughout Ireland; for more information go to www.berkley-If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone David O'Connell at or send your CV to -