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Process Scientist

  1. Midlands (Ireland)
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
19-09-2023
32011
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Process Scientist – Manufacturing Technology – 12-Month Contract

Are you looking for your next contract assignment? Our client, a leading pharmaceutical organisation, are recruiting for a Process Scientist to join their newly assembled team and help contribute towards the development of their next core projects.  

As a Process Scientist, you will be a key contributor to a dynamic and highly technical team. You will be responsible for new product introduction, technology transfers, process validation, and continued process technical support to unit operations for the commercial manufacture of multiple processes in the client’s facility.

Responsibilities
  • Support new product introduction, process technology transfer, process validation and the preparation of CMC documentation for regulatory filings.
  • Provide hands-on technical support for manufacturing process activities and support team input to investigations and resolution of process deviations, root cause analysis, CAPAs, process improvements, change controls and preparation of regulatory filings.
  • Accountable for delivery of upstream and downstream technical documents, including protocols, reports and SOPs supporting the validation of the manufacturing process.
  • Strong knowledge of cGMP compliance, site and regulatory agency requirements and provides process subject matter expertise for regulatory inspections and other interactions with regulatory agencies.
  • Participates in continuous improvement initiatives, action plans to implement operational excellence, and lean practices along with setting and maintaining department goals and metrics.
Requirements
  • BSc, MSc or PhD, in a relevant discipline (e.g biotechnology, biochemistry, process engineering) or equivalent experience.
  • 2+ year’s experience in pharmaceutical manufacturing organisation and/or bio-process development, with experience in upstream or downstream unit operations, process scale up, facility fit and process validation.
  • Experience with large scale manufacturing support for mammalian cell culture, upstream and downstream processing, Single Use Systems, cGMP and US / EU regulations.
  • Ability to develop, build, present and defend technical and scientific approaches in both written and verbal form. .
  • Be proficient in ETS, SAP, Veeva Vault, strong knowledge of Excel, Word, and PowerPoint desirable.
  • Experience in the design, modification and optimisation of upstream and/or downstream processes.
  • Understanding of project management systems and tools. Management of multiple projects and time-lines concurrently.
  • Experience in process optimisation, characterisation and troubleshooting for manufacturing processes.
  • Knowledge of Statistical Process Control, Computer Modelling, Data Analytics, and related tools
If this job is of interest to you, apply now.



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