Process Engineer (Aseptic Sterile Fill Finish)

  • Sligo
  • Permanent
  • JO-1903-64329_1565258103

Summary

Process Engineer - Aseptic Sterile Fill Finish

As part of this expansion we are currently sourcing a Technical Operations Process Engineer who will be responsible for providing technical and engineering support from a formulation perspective, and to develop new and innovative processes to deliver cost reductions in line with Operations and Quality requirements to support the Manufacturing process for Biologics manufacturing.

Key Responsibilities:

· To provide technical and engineering support, daily trouble shooting, optimisation, cost reduction, training and coaching of manufacturing personnel.

· Leadership of manufacturing and validation activities during project life cycle.

· Perform gap analysis, facility fit studies, process safety and risk analysis for the newly introduced process.

· 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.

· Identification and project management of continuous improvement projects. Work closely with other departments to deliver these continuous improvement projects.

· Preparation of feasibility studies and operating budgets for future product introductions to the site.

· Planning and leadership of technical transfers for future product introductions to the site.

· Work closely with MS&T and GPRD, on the process development of suitable future products.

Required Experience:

· B Eng. or BSc. or relevant technical qualification

· 5 years' experience in pharmaceutical process engineering, with relevant experience of batch processing, technical transfers, 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 preferable

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