Job Description
A fantastic and exciting opportunity has arisen for a
Manufacturing Biotech Associate
.
This role will involve working shift, on a 24/7 basis.
This role is a site based position.
The Manufacturing BioTech Associate will work in a manufacturing self-directed shift team to deliver batch operations successfully, identify and resolve issues in order to allow the site to deliver for our patients in a culture that supports Quality, EHS, Learning and Continuous improvement.
Our facility in Dunboyne joined our network in September ****.
Our Dunboyne site is our Company's first Biologics Drug Substance Single Use Commercialisation Facility, playing an important role in helping to commercialise key medicines.
The cutting-edge innovation and collaboration between our Company's research and manufacturing teams will significantly accelerate the time it takes to bring a medicine to market for the benefit of patients around the world.
Bring energy, knowledge, innovation to carry out the following:
The production of biologic drug substance on their designated shift team and will be responsible for the preparation, operation and monitoring of equipment, use of business systems and carrying out tasks including but not limited to the cleaning, validation, in-process testing.
The progression of an automated recipe using paperless technology in order to generate the drug substance through inoculation and cell culturing activities directing to filtration and purification of the product.
Setting up the single use equipment between runs, carrying out the production process according to world class GMP and EHS standards and driving to optimise and improve the processing activities through use of standard work and lean processing techniques.
Focusing on delivery to the patient through living the Dunboyne culture including a commitment to safety, focusing on right first time in everything we do and concentrating on the engagement and development of self and peers.
What skills you will need:
A science qualification in a technical, engineering or science-based discipline or equivalent.
0 to 3 years' experience in the biotechnology and/or pharmaceutical industry or equivalent.
Experience in a highly regulated pharmaceutical manufacturing environment.
Good understanding in the production of biologic drug substance and experience an advantage.
Ability to work as part of a shift team and on own initiative in a constructive manner.
Ability to think logically and be proactive under pressure.
Flexible and self-motivated.
As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
Required Skills:
Analytical Problem Solving
Cell Cultures
Computer Literacy
Corporate Productions
Data Entry
Equipment Maintenance
GMP Compliance
GMP Documentation
Good Manufacturing Practices (GMP)
Key Performance Indicators (KPI)
Manufacturing Compliance
Manufacturing Documentation
Manufacturing Operations
Manufacturing Processes
Manufacturing Quality Control
Media Preparation
Motivating Teams
Organizational Structures
Process Improvements
Process Manufacturing
Production Processes
Quality Control Management
Regulatory Compliance
Safety Practices
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