Overview
Lead Manufacturing Biotech Associate role at MSD in Dunboyne, County Meath, Ireland. The role is part of the Manufacturing Self Directed work team/ Hub in a new state-of-the-art single-use multi-product biotech facility. 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 emphasises Safety First, Quality Always, and a continuous improvement mindset. Objectives should be achieved in compliance with safety and quality requirements 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, aiming for Right First Time (RFT).
* Author, review, and/or edit procedures and technical documents to comply with cGMP requirements.
* Provide coaching to shift teams on the RFT documentation approach.
* Ensure that all tasks related to manufacturing documentation support 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 supported with improvement actions, and participate in investigations related to manufacturing documentation 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 when required.
Qualifications and Skills
* Bachelors Level 8 degree in science, engineering, or other technical discipline, or a Level 7 qualification with a minimum of 5 years’ experience in a GMP-regulated environment.
* 5 years of experience in a regulated GMP environment.
* 3 years of experience in the Biopharma industry, with direct experience of biologics manufacture desirable.
* Proven track record in a regulated industry.
Company and Work Model
We are committed to keeping the patient at the heart of all we do and to flexible working where possible. This role supports a hybrid working model for office-based colleagues. Please discuss flexibility during the application process.
Additional Information
As an equal opportunity employer, we value diverse, talented, and committed people. For support during the recruitment process, contact the assigned Talent Acquisition Advisor. The position is Regular, Full-time. Location: Dunboyne, County Meath, Ireland.
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