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Senior NPI Engineer

Job description

Senior NPI Engineer

My client, a leading pharmaceutical company, based in Co. Mayo is looking for an experienced Senior NPI Engineer to join their site. You will take ownership for all New Product Introductions into the Biologics Pharma Tech Group.

Your 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 Core 1 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

  • MSC (ideally) with 3 years or Bachelor’s Minimum of 8 years in a relevant environment with applicable experience

 

Technical Skills and Experience

  • 3-5 years’ experience with commercial & / or clinical manufacture 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 more information, please contact Emma on 091 455 307.

 

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