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PROCESS ENGINEER NSI
Company:CPL |
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Job Reference Number |
14572119 |
Client ID: |
RI/JO-1202-242304A |
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Posted On: |
Feb 22 2012 |
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Location: |
DUBLIN, KILDARE, WICKLOW, DUBLIN WEST |
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Job Type: |
Contract |
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Salary: |
NEGOTIABLE |
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Department: Technical Services
Position Reports to: NSI Tech Services Lead for particular project
Job Purpose
Provide process engineering and manufacturing technology support to the NSI projects - transfer of Pegylation and Purification processes. This role focuses on facility and equipment design, knowledge capture, assisting in equipment commissioning and qualification, technology transfer execution including execution of studies on the bench or at scale in support of these processes. The initial phase will entail working the donor site and with third party engineering companies to implement the most appropriate facility design to accurately transfer the process as it stands at the donor sites. The latter part of the project will involve the start up of the facility and it will end with the close out of the process validation and regulatory filing submissions.
The job-holder works with the Technical Services Teams to deliver integrated technical services to meet the Drug Substance PPU business objectives.
The job maybe a requirement to second to the process donor site for training and knowledge capture purposes.
Job Responsibilities:
1. Capture knowledge from donating site through review of documentation, observation of batches, compiling process descriptions and flow diagrams, interacting and training with donating site personnel.
2. Take part in Gap Analyses and Risk Assessments to support the tech transfers
3. Write and maintain the Tech Transfer Plan and Tech Transfer Documents.
4. Help maintain the process model/mass balance for the processes
5. Model the running of the facility with Operations - number of batches, scale of equipment, facility sizing and layout, etc
6. Capture the all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is started up at the host site.
7. Liaise with 3rd party engineering consultants to ensure the project requirements are accurately followed
8. Ensure the process automation meets the requirements of the process
9. Assist in the raising and execution of change controls for Technical Services
10. Provide process expertise for trouble-shooting and resolution of manufacturing process and technology issues.
11. Provide process engineering expertise to support from preliminary engineering through to the end of process validation and delivery of the facility to Operations.
12. Own the Process Flow Diagrams (PFDs) and P&IDs.
13. Provide technical training on process and technology areas as required by the project.
14. Support Compliance Inspections and enquiries from Regulatory Agencies.
15. Develop and maintain productive links with process equipment & technology supplier and vendors.
Experience
1. A minimum of 5 Years cGMP industrial experience, ideally covering Operations, Engineering, Projects and Validation within bioprocess manufacturing.
2. In depth understanding of process engineering including biotechnology, purification technology and unit operations, potential impact of equipment on biological molecules.
3. Experience working with automated control systems.
4. Experience with technology transfer and project engineering preferred.
5. Experience of pegylation processes preferred
6. Industrial chemistry experience at bench or commercial scale would be advantageous
7. Process chromatography experience would be an advantage
8. Experience of FDA and EU licensing and inspection.
Education
Minimum qualification of a B.Sc. Degree in Engineering, Science or equivalent with particular emphasis in Biochemical, Chemical or Mechanical discipline.
