Process Engineer NPI

2021-12-22 16:01:072049-05-22Team Horizon
Job TypeContractor
AreaWestmeathWestmeathIreland
SectorEngineering
Start Date
AdvertiserHilda Lynn
Telephone+353 98 33013
Job Ref#1002301
Job Views253
Description
Process Engineer NPI – Team Horizon
 
Team Horizon have an exciting opening for a Process Engineer to join our client’s Tech Services team within their pharmaceutical manufacturing site in Athlone.
 
What you will be doing:
  • As the Technology Transfer/Process Engineer you will provide key technical leadership and support in the areas of new product introduction, development batch planning/execution and product launch activity technical support.
  • You will ensure that a TT/NPI plan is developed, and all required documentation is generated to support same. You will work cross functionally with Operations, Quality, Engineering etc. to successfully qualify and validate the new product.
  • You will also support manufacturing process troubleshooting and continuous improvement initiatives as required.
  • Leads technology transfer and other development projects from a scoping, technical assessment, and technical management perspective. This includes developing procedures, protocols, plans and risk assessments.
  • Supports international regulatory filings through the authoring or review of relevant submission documents as required.
  • Provides regular updates to management on technology transfer project plans, status and risks/mitigations.
  • Responsible for developing and rolling out new systems on site such as Continuous Process Validation (e.g., CPP trending)
  • Is part of a process SME team for our client’s products, supporting or leading product related deviations, change controls and CAPAs where required.
  • Support manufacturing by leading/supporting deviation investigations and is familiar with
structured problem solving and root cause analysis.
 
What you need to apply:
  • At least 5 years relevant experience in a pharmaceutical manufacturing environment, with at
  • least 3 years’ experience in a comparable process engineering/technical services role.
  • Experience leading technology transfer projects and supporting product launches would be an advantage.
  • Bachelor’s Degree in Engineering, Pharmaceutical Sciences, or related Science discipline.
  • Specific knowledge of sterile pharmaceutical manufacturing processes and technologies. Ideally, aseptic filling operations.
  • Broad knowledge of NPI with ability to lead or support any NPI into the site.
  • Knowledge of best practices in pharmaceutical product development, scale-up and technology transfer.
  • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently.
 
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