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 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.
• 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 planning of tasks is effective and linked into the
manufacturing process plan.
• Support approved projects and continuous improvement initiatives that are in alignment with site
strategies.
• Be an advocate for continuous improvement
• 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
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 is 24/7 - 4-Cycle shift -