Job Detail

Location Mayo
Salary Negotiable
Role Type Fixed Term Contract
Contact Deirdre Finnerty

NPI Engineer

Senior NPI Manager

Our client a leading pharmaceutical company is recruiting for a Senior NPI Manager for their site in Mayo. As the senior manager, you will take ownership of all New Product Introductions. This role is commutable from Sligo County.

Key Responsibilities

  • Project management of all Biologic NPIs
  • Coordinate with New Products Development groups to develop and complete strategies for new products.
  • Developing manufacturing compounding processes for the drug product being introduced to fit the facility
  • Provide technical support to all aspects of batch manufacturing activities, in accordance with site SOPs and multiple product controls
  • Updating / generation of SOPs/ Risk Assessments and manufacturing documentation
  • Support installation of new equipment as required
  • Completion of quality records in QMS
  • Support Budgets and yearly R&D Tax Credits technical documents

Education, Experience, and Skills required:

  • MSC with 3 years or Bachelor’s Minimum of 8 years in a relevant environment with applicable experience
  • 3-5 years’ experience with commercial & / or clinical manufacturing processes
  • Understanding requirements of cross contamination controls in multi-product facility
  • Understanding of aseptic practices in clean room environment
  • Responds to change with agility and helps others navigate through change
  • Technically minded
  • Proven ability to problem solve
  • Must be a self-starter with a pro-active approach
  • Experience with interacting in project teams.
  • Good technical writing skills.
  • Good time management and organizational skills.
  • Understanding of GMP
  • Must be a self-starter with a pro-active approach
  • Flexibility of working hours may be required, and shift work may be required upon request
  • Experience with GMP regulatory inspections

For further information on this Senior NPI Manager role in Mayo please contact Deirdre Finnerty on 086 3073779/

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NPI Engineer

Deirdre Finnerty

Role Type Fixed Term Contract
Contact Deirdre Finnerty
mobile +353 86 307 37 79
linkedIn profile click here

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