Lead Manufacturing Bioprocess Associate-Shift
- Co Meath
- Permanent
- Full-time
- An amazing opportunity has arisen for a Manufacturing Bioprocess Associate to provide operational support for manufacturing operations of the Late Stage and Launch Pipeline products at our new state of the art single use biotechnology facility in Dunboyne, Ireland.
- The client serves as a magnetic force that attracts, recognizes, and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Dunboyne, but that the facility belongs to and is shaped by them.
- The Lead Manufacturing Bioprocess Associate will 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
- Provide guidance, coaching and mentoring to the rest of the production team
- 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 a key requirement.
- Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
- Conduct all work activities with a strict adherence to the safety and compliance culture on site
- Support the Authoring of electronic batch records, sampling plans, work instructions and standard operating procedures.
- Lead, facilitate and participate daily in cross-functional teams to collaborative effectively to ensure compliance
- Bachelor’s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering.
- 5 years + Biotech Industry (bulk manufacturing of pharmaceutical or biological components)
- Competent in troubleshooting and show practical problem-solving capabilities.
- Ability to work independently and within a cross-functional team.
- Understanding of multi column chromatography concepts
- Familiarity with contamination control and batch release requirements
- Familiarity with Emerson DeltaV, Pas X, and the use of Automation in a manufacturing Process.
- Proficiency in various SingleUse technologies in a manufacturing environment
- Problem, Deviation, and Change Management experience
- Commissioning and Qualification experience
- Experience of Upstream and Downstream Unit Operations for mAb manufacturing with in depth knowledge of key unit operations.
- Understanding of both continuous and batch fed manufacturing processes
- Experience leading, presenting, or supporting Regulatory Inspections and Site Internal Audits