Upstream Manufacturing Process Specialist
This is an exciting opportunity for a skilled professional to join our team in Cork. As an Upstream Manufacturing Process Specialist, you will play a crucial role in representing operations on capital project teams and supporting the first line of troubleshooting within the manufacturing department.
1. You will represent Operations on cross-functional project implementation teams, ensuring seamless collaboration and effective communication.
2. Maintaining and improving the manufacturing process and equipment will be your primary responsibility, including monitoring, troubleshooting, and optimizing processes to meet quality and efficiency standards.
3. Monitoring and reporting process performance using statistical process control will be essential to ensure data-driven decision-making.
4. You will troubleshoot DCS (e.g., Delta V) and PLC control systems, resolving issues promptly to minimize downtime and maintain production schedules.
5. Investigating and resolving issues raised within the manufacturing department will require strong analytical and problem-solving skills.
6. You may participate in or lead cross-functional teams as required, promoting a culture of collaboration and open communication.
7. Supporting commissioning and qualification activities will be critical to ensuring that new equipment and processes meet regulatory requirements.
8. Preparing and updating batch records, procedures, and work instructions will require attention to detail and organizational skills.
9. You will provide process and equipment-related training as required, sharing your expertise with colleagues to enhance their knowledge and skills.
10. Completion of assigned tasks will support the manufacture of high-quality biomedicines in accordance with cGMP and EHS requirements.
Requirements
* A bachelor's degree in a scientific or technical discipline is required.
* A minimum of 5 years' experience in a quality, validation, or compliance role within the biological and/or pharmaceutical industry is essential.
* Industry experience in upstream fed-batch bioreactors is highly desirable.
* Familiarity with DCS (e.g., Delta V), SCADA, and PLC systems is necessary.
* Manufacturing experience within a GMP-regulated environment is required.
* Experience of cell culture or purification processes and project/new equipment installation experience are highly valued.
If you are interested in this opportunity, please contact us for further information.