Overview
Lead Manufacturing Biotech Associate. This role will be part of the Manufacturing Self Directed work team/Hub in a 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. The role involves supporting the manufacturing process while fostering an inclusive culture that emphasizes Safety First, Quality Always, with a continuous improvement mindset. Ensure objectives are effectively achieved, consistent with our requirements to ensure compliance, safety and 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, Right First Time (RFT).
* Author, review, and/or edit procedures and technical documents to ensure cGMP compliance.
* Provide coaching to shift teams on the RFT approach to documentation.
* Ensure manufacturing documentation support is in accordance with good manufacturing practices.
* Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate.
* Support safety walkdowns, audits/inspections, risk assessment, and action implementation.
* Ensure incident investigations are supported with improvement actions and participate in investigations related to manufacturing documentation.
* 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 during handover.
Any other duties as assigned by the Manager, such as acting as a designee for Manufacturing Shift Lead as required.
What Skills You Will Need
In order to excel in this role, you will more than likely have:
* 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 desirable.
* Proven record of accomplishments in a regulated industry required.
As a company, we are committed to keeping the patient at the heart of our work and to finding solutions and treatments for healthcare needs.
As an equal opportunity employer, we are proud to embrace the value of bringing diverse, talented, and committed people together. Please contact the Talent Acquisition Advisor assigned to this role should you need any support during our recruitment process.
We are committed to flexible working where possible, and this is why our Company has introduced a hybrid working model for office-based colleagues. Please speak about flexibility during your application.
Additional Information
Job Posting End Date: 10/15/2025. This posting is effective until 11:59 PM on the day before the listed end date. Apply accordingly.
Requisition ID: R367566
Employment type: Full-time — Regular
Location: Dunboyne, County Meath, Ireland
Relocation: Not Applicable
Visa Sponsorship: Not specified
Travel Requirements: Flexible
Shift: Not specified
Hazardous Materials: Not specified
EEO Statement: As an equal opportunity employer, we value diversity and are committed to creating an inclusive environment for all employees.
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