Overview
A Lead Manufacturing Biotech Associate role in Manufacturing Self Directed work team/ Hub at a new state-of-the-art single-use multi-product biotech facility in Dunboyne, County Meath, Ireland. The organisational structure at the site is based on self-directed work teams where decisions are made at the level where the data exists. The Lead Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and collaboration skills. This role supports the manufacturing process while promoting an inclusive culture with a Safety First, Quality Always, and continuous improvement mindset. Objectives are to be achieved in compliance with safety requirements and to provide a reliable supply to customers.
Responsibilities
* Carry out and support operations to achieve assigned duties.
* Deliver shift standard work for a team-based approach to batch progression.
* Document executed activities to ensure accountability and traceability of production records and Right First Time (RFT).
* Author, review, and/or edit procedures and technical documents to ensure compliance with cGMP requirements.
* Provide coaching to shift teams on the RFT approach to documentation.
* Ensure manufacturing documentation support tasks comply with good manufacturing practices.
* Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate.
* Support safety walkdowns, audits/inspections, risk assessments, and implementation of agreed actions.
* Ensure incident investigations are fully supported with improvement actions and participate in investigations arising from manufacturing documentation aspects as required.
* Coach and oversee on the shop floor to identify potential issues before they arise.
* Lead approved projects and continuous improvement initiatives aligned with site strategies.
* Run handover boards and provide key updates to shift leads for handover.
* Other duties as assigned by the Manager, including acting as a designee for Manufacturing Shift Lead as required.
Qualifications and Skills
* Bachelors Level 8 degree in science, engineering, or other technical discipline, or a Level 7 qualification in a science or engineering discipline with at least 5 years’ experience in a GMP regulated environment.
* 5 years’ experience in a regulated GMP environment.
* 3 years’ experience in the Biopharma industry, with direct experience of biologics manufacture desirable.
* Proven record of accomplishments in a regulated industry.
Additional Information
As a company, we are committed to keeping the patient at the heart of all that we do and strive to find solutions for challenging healthcare needs. We are an equal opportunity employer and value diversity. Please contact the Talent Acquisition Advisor assigned to this role if you need support during the recruitment process. We are committed to flexible working where possible and have introduced a hybrid working model for office-based colleagues. Feel free to discuss what flexibility means to you during your application.
So, if you are ready to invent solutions to meet unmet healthcare needs, please apply today.
Job Posting End Date: 10/15/2025
#J-18808-Ljbffr