Biotech Associate
The 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 -