Job Description
A fantastic opportunity has arisen for a Lead Manufacturing Biotech Associate. This role will be part of Manufacturing Self Directed work team/ Hub in the new state of the art single use multi-product biotech facility in Dunboyne, County Meath, Ireland.
The Lead Manufacturing Biotech Associate is a leader with strong interpersonal, communication, and collaboration skills. The Lead Manufacturing Biotech Associate is responsible for supporting the manufacturing process, while creating an inclusive culture that energizes a Safety First, Quality Always, with a continuous improvement mindset.
Ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety and provide a reliable supply to our customers.
Bring energy, knowledge, innovation to carry out the following:
* Carry out and support operations to achieve assigned duties.
* Deliver shift standard work for a team-based approach to batch progression.
* Document executed activities necessary to allow proper accountability and traceability of production records, Right First Time (RFT).
* Author, review, and/or edit procedures and technical documents to ensure the documents are in accordance with cGMP requirements.
* Provide coaching to the shift teams on the RFT approach to documentation.
* Ensure that all assigned tasks related to manufacturing documentation support is in accordance with good manufacturing practices.
* Identify, escalate and address compliance, environmental, safety, and process deviations as appropriate.
* Support execution of safety walkdowns, audits/ inspections, risk assessment, implementation of agreed upon actions, etc.
* Ensure incident investigations are fully supported with improvement actions implemented and participate in investigations arising from manufacturing documentation aspects as and when required.
* Coach and provide oversight on the shop floor to identify potential issues before they arise.
* Lead approved projects and continuous improvement initiatives that are in alignment with the site strategies.
* Run handover boards and provide key updates to shift leads for handover.
Any other duties as and when assigned by the Manager. Such as act 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 would be desirable.
* Proven record of accomplishments in a regulated industry required.
We are an equal opportunity employer, committed to keeping the patient at the heart of all that we do and strive to find solutions and treatments for some of the world's most challenging healthcare needs.
We are committed to flexible working where possible, and this is why our Company has introduced a new hybrid working model for office-based colleagues around the world.
Please feel free to speak to us about what flexibility means to you during your application.
So, if you are ready to:
Invent solutions to meet unmet healthcare needs, please apply today.
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