
Senior Manufacturing Operations Specialist
4 days ago
We are seeking an experienced Manufacturing Operations Specialist to join our team in Dunboyne, Ireland. In this role, you will provide operational support for manufacturing operations of Late Stage and Launch Pipeline products at our state-of-the-art single-use biotechnology facility.
This is a fantastic opportunity to work with a dedicated process team where flexibility and teamwork are key requirements. As a Manufacturing Operations Specialist, you will be responsible for supporting end-to-end production operations for both Fed Batch and Continuous Manufacturing. You will also lead/guide team members to support on-floor manufacturing of pipeline products on a shift rotation, operate equipment according to electronic batch records, sampling plans, and standard operating procedures, and conduct all work activities with a strict adherence to the safety and compliance culture on site.
The ideal candidate will have a Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering, and 5+ years of experience in the Biotech Industry (bulk manufacturing of pharmaceutical or biological components). You will be competent in troubleshooting and problem-solving, able to work independently and within a cross-functional team, and proficient in various SingleUse technologies in a manufacturing environment.
We are looking for someone who can lead, facilitate, and participate daily in cross-functional teams to collaboratively ensure compliance. If you have experience of Upstream and Downstream Unit Operations for mAb manufacturing, Commissioning and Qualification, and regulatory inspections, we would love to hear from you.
Key Responsibilities:
- Support end-to-end production operations for both Fed Batch and Continuous Manufacturing
- Lead/Guide team members to support on-floor manufacturing of pipeline products on a shift rotation
- Operate equipment according to electronic batch records, sampling plans, and standard operating procedures
- Work as part of a dedicated process team where flexibility and teamwork are key requirements
Requirements:
- Bachelor's degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering
- 5+ years of experience in the Biotech Industry (bulk manufacturing of pharmaceutical or biological components)
- Competent in troubleshooting and problem-solving
- Ability to work independently and within a cross-functional team
- Proficient in various SingleUse technologies in a manufacturing environment
Preferred Skills:
- Experience of Upstream and Downstream Unit Operations for mAb manufacturing
- Commissioning and Qualification experience
- Regulatory inspection experience
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