Biochemical Pharma Science Equipment Validation Contract Dublin Process Engineer Temporary Cleaning Validation Process Scientist Technology Transfer Ireland Biotech Biochemistry Contractor Process Validation Tech Transfer Biological Engineering Method Validation Biotechnology Chemical Pharmaceutical Job Validation Scientist Bioprocess Engineering
Dublin South Dublin West
3 - 4 Years
Third Level Degree
This is initally a 12 month temporary contract, working on a tech transfer project. Subject to business requirements and personal performance, their may be scope for contract extension.
Interviews will be held within the next 5-7 working days.
For more information on the position, please send your CV to Jenny Navan for review, or call 016146072 or email Jenny.Navan(at)cpl.ie
Provide process science and validation support to the ongoing requirements of the respective Drug Substance and Parenterals business units, as well to support process tech transfer projects into site. The process scientist is responsible to ensure that the process is running as intended, that it is appropriately validated and run so as to maintain that validated state.
This role focuses on process monitoring and trouble-shooting, including leading/supporting major process investigations, implementation of cost reduction projects, facility and equipment design specification, knowledge capture from donor sites, assisting in technology transfer execution including process trials on the bench or at scale in support of these project objectives and execution of final process and cleaning validation studies and write-ups.
The job-holder works with the Technical Services Teams to deliver integrated technical services to meet the site business objectives. The role may entail specialization and training in process science and technology to meet overall site business needs for technical support e.g. Training cell culture, conjugation chemistry, syringe filling, informatics, bioprocess engineering, etc. As such as strong overlap into process engineering and validation disciplines is expected of the process scientist.
- Lead the implementation of projects to optimise plant and process productivity. These can include
· Process robustness / capability improvements
· Yield improvements
· Process capacity improvements
· Process scale-ups
· Introduction of new technology including process analytical technology (PAT)
· Introduction of new or alternate consumables or raw materials
· Optimising re-use of filters and columns gels, sampling plans, consumable usage
- Lead or support major process investigations, and support the implementation of process CAPAs.
- Write product/process impact assessments in support of significant investigation closures.
- Work to implement a culture of Right-First Time through partnerships with Operations and other functions on site, and provide leadership in the use of OE principles to optimise our technical and business processes.
- 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.
- Capture the all aspects of the existing process and equipment at the donor sites to ensure that an equivalent process is started up
- Participate in Gap Analyses and Risk Assessments to support the tech transfers
- Write Tech Transfer and Validation/Verification Documents.
- Liaise with site functions - Logistics Operations, Planning, QA, QC, Operations, Regulatory Affairs to support the process transfer and project implementation
- Raise, investigate and complete investigations and commitments relating to technical Services responsibilities
- Assist in the raising and execution of change controls for Technical Services
- Carryout process capability analysis on all commercial processes on a periodic basis, typically quarterly if run rate allows. Identify areas for improvement where process capability is deemed to be unacceptable.
- Support for preparation and review of the relevant sections of the Annual Product Quality Reports (APQR)
- Process validation execution in support of major process changes
- Cleaning validation execution, including periodic re-validation, in support of Operations
- Shipping validation execution in support of Supply Chain Support
- Review site change controls to ensure the validated state of a process is not impacted by a proposed change.
- Provide process expertise for trouble-shooting and resolution of manufacturing process and technology issues.
- Prepare and execute process and cleaning validation protocols. Write up the associated summary reports and support the submission summary preparations.
- Provide technical training on process and technology areas as required by the project.
- Provide support for filing submissions and assist in the response to regulatory queries.
- Lead the implementation of regulatory process follow-up measure commitments.
- Transfer as required onto project roles or to support other technical support roles as required by the business eg. move to support a different business unit within Technical Services