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Details
Technical Support Specialist - Drug Substance
| Reference: | SMC8274 | Location: |
Louth |
| Qualification: | Degree | Experience: | See description |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Technical Specialist
We’re currently recruiting for an exciting opportunity with an award-winning biopharmaceutical organization based in Dundalk. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Key Responsibilities:
- Provide Technical Support within the Drug Substance manufacturing team including areas such Cell expansion, Bioreactor and Downstream.
- Execution of equipment qualification deliverables during execution of project phase including equipment Commissioning & Qualification, IOQ.
- Coordinate technical deliverables within Drug Substance to support the successful product launch.
- Provide technical support to the operations team’s during commercial manufacturing.
- Lead/participate in manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis is completed and appropriate CAPAs are implemented.
- Support Batch Disposition activities by providing SME technical support for comment resolution.
- Identify and implement projects to continuously improve the compliance and manufacturing capabilities within the Drug Substance.
- Support continuous process and quality improvements through the deployment of Lean Six Sigma tools.
- Creation and revision of technical documents including manufacturing batch records, SOPs, and technical memos.
- In partnership with the site MS&T scientist the Principal Technical Support Specialist will provide comprehensive technical leadership to the DS organization.
- Minimum 3 years working in biological, vaccine or pharma facility. Preferred candidate will have cGMP with biological, vaccine or pharma facility with prior sterile manufacturing experience.
- Ability to operate within a matrix team to execute on the floor activities such as FAT, SAT, IQ/OQ and Engineering batches.
- Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g., Six Sigma
- Experience in a risk-based approach to manufacturing through use of tools such as FMEA
If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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