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* 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 cleaning, validation, in-process testing.
Duties
* 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 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 optimize and improve the processing activities through use of standard work and lean processing techniques.
* Focusing on delivery to the patient by 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.
* Maintain a high standard of safety/GMP compliance at all times.
* Maintain a high level of personal expertise and working knowledge of all aspects of the manufacturing process and process equipment through continuous training and development.
* Liaise with other groups and individuals to ensure effective planning of tasks linked to the manufacturing process plan.
* Support approved projects and continuous improvement initiatives aligned with site strategies.
* Be an advocate for continuous improvement.
* Experience in a highly regulated pharmaceutical manufacturing environment.
* Good understanding of biologic drug substance production; experience is 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.
Requirements
* 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.
Shift
24/7 - 4-Cycle shift
Seniority level
* Entry level
Employment type
* Full-time
Job function
* Management and Manufacturing
Industries
* Biotechnology, Pharmaceuticals
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