Back to Job Search

NPI Process Engineer

  • Sector: Science & Pharma
  • Contact Email: davin.ferguson@collinsmcnicholas.ie
  • Job Ref: 20182

Process Engineer

Would you like to work with a leading Biopharma company on their first new product introduction at a new state-of-the-art aseptic fill-finish building. You will join a highly technical team to support new product introductions and equipment development to cater for new products being introduced to the site.

 

As Process Engineer at this new multi-million euro state-of-the-art facility you will be responsible for providing technical and scientific support in the production of biological drug products. You will be heavily involved with tech transfer and new product introduction of parental and lyophilization products into the facility and to support the manufacturing process in line with Operations and Quality requirements.

 

Key Responsibilities:

  • To provide technical support for the aseptic filling and lyophilization of biological drug product.
  • Become competent in the aseptic filling process and isolator technology at the site.
  • Participate in planning and coordinating technology transfers and new product introduction activities into the facility.
  • Understand the drug product process behaviour by evaluating process and technical data, literature, and work closely with S&T organization in the design of experimental strategies.
  • Support process investigations, primarily by seeking scientific/technical root causes and liaise with S&T to perform lab-related investigations if required.
  • Assist with product impact assessment for change controls and internal/external investigations as required.
  • Monitoring and analysis of process data during the manufacturing of drug product.
  • Identification and project management of continuous improvement projects. Work closely with other departments to deliver these continuous improvement projects.
  • Work closely with the global science and quality teams, on the process development of suitable future products
  • Continuously drive to improve processes for improved performance and cost reduction wherever possible.

 Experience/Qualifications

  • Relevant engineering or science degree
  • Minimum of 3 years’ experience in pharmaceutical process engineering, with relevant experience in some of the following; batch processing, technical transfers, NPI’s, scale-up, commissioning and validation in a cGMP pharmaceutical or Biologics industry
  • Experience in new product introductions to Biologic facilities is desirable
  • Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements are required
  • Experience working with lean methodologies is desirable. 
  • Previous experience in lyophilization and sterilization operations is advantageous.

We are initially looking at contractors for these roles while in Project phase. The rate are competitive and if desired there are plenty of opportunities to develop your career further within this large and expanding multinational group.

*******************************************************************************************

For a confidential discussion and more information on the role, please contact Davin Ferguson

davin.ferguson@collinsmcnicholas.ie

071 9140251