Process Development Associate
2 days ago
As a Bioprocess Operations Specialist, you will play a critical role in supporting the manufacturing activities of a leading multi-national Biotech client based in Ireland. You will work closely with a multi-disciplined team to ensure that all operations are carried out in accordance with established procedures and regulations.
The ideal candidate will have a strong understanding of bioprocessing principles and practices, as well as experience working in a GMP manufacturing environment. You will be responsible for operating equipment, conducting troubleshooting, and supporting the authoring of technical documents.
Key Responsibilities:
- Ensure that all operations are carried out in accordance with established procedures and regulations.
- Operate equipment according to electronic batch records, sampling plans, and standard operating procedures.
- Conduct troubleshooting and support the resolution of technical issues.
- Support the authoring of electronic batch records, sampling plans, work instructions, and standard operating procedures.
Requirements:
- Level 7 qualification in a science or engineering discipline desired.
- A level 6 with a minimum of 3+ years experience in a GMP Manufacturing requirement shall be deemed equivalent.
- Competent in troubleshooting and show practical problem-solving capabilities.
- Ability to work independently and within a cross-functional team.
- Familiarity with contamination control and batch release requirements.
- Familiarity with Emerson Delta V, Pas X, and the use of automation in a manufacturing process.
- Proficiency in various Single Use technologies in a manufacturing environment.
- Commissioning and Qualification experience.
- Understanding of Upstream and Downstream Unit Operations for mAb manufacturing.
- Understanding of both continuous and batch fed manufacturing processes.
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