Manufacturing Projects Scientist

Role Title: Upstream/Downstream Manufacturing Support Scientist

Location: Dublin 15

We are currently working with a Biopharmaceutical Manufacturer in Dublin 15 who are seeking to recruit a contract Manufacturing Support Scientist/Engineer, reporting into the Associate Director for new product introduction within the Manufacturing group.

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• Contributes to cross functional team (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) for process improvement implementations, new product start-ups or other process changes.
  
• Support new product introduction risk assessments to ensure the appropriate controls are in place to enable manufacturing.
  
• Support product change over protocols to allow a smooth transition from sustaining to new product manufacturing.
  
• Represent the Manufacturing at meeting to ensure the end user requirements are represented
  
• Supports process technology transfer, and the preparation of manufacturing documentation for development, engineering and PPQ batches.
  
• Identify process improvement projects for New Product Introduction and support projects to completion.
  
• Work with sustaining team to understanding current issues and ensure impact of new products are defined, agreed and understood.
  
• Write process impact assessments to support new product introduction.Provide SME input into cross-functional teams investigating & optimizing new manufacturing processes, procedures and documentation.
  
• Provide training to BPAs on new procedures.
  
• Support external and internal audits.
  
• Work with cross-functional teams on the introduction of consumables and raw materials to support New Product Introduction.
  
• Work to implement a “Right-First Time Culture” and provide leadership in the use of OE principles.
  
• Support the disposition process when required
  
• Carry out organizational activities such as purchasing & co-coordinating communication information.
  
• Own & drive change controls, CAPA’s, investigations, improvement projects and operational safety.
  
• Minimize human error and work with operations to remove sources of error.
  
• Departmental Approver of operations procedures, electronic batch records and other GMP documentation and provide technical training and knowledge transfer to the Operations team.
  
• Support sustaining operations when required to ensure product supply
  
• Develop strong working relationships with Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources, Finance.
  
• Support and implement new technology solutions such as Single-Use technology.
  

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• 3-4 years experience in Upstream or Downstream Manufacturing.
  
• Bachelors/Masters in Science, Engineering, or a related subject.
  
• In-depth theoretical knowledge of GMP biologics manufacturing equipment and process automation. xcfaprz
  
• Proven ability to support the closeout of complex technical investigations.
  
• Strong working knowledge of systems such as Delta V, MES Syncade and SAP.