Process Development Specialist

2 days ago

Sligo, Sligo, Ireland beBeeDevelopment Full time €60,000 - €80,000

Job Opportunity:

We are seeking a highly skilled Process Development Specialist to join our team in Sligo. The successful candidate will work closely with cross-functional teams and global science and quality teams to develop and evolve single-use materials used in biologics manufacturing processes.

The ideal candidate will have strong collaboration skills, be initiative-taking, and able to work to strict project timelines. They will lead and assist risk assessments for the introduction or modification of product paths, interact with manufacturers and vendors on best practices, and function as technical lead for SU complaints.

Responsibilities:

  • Process Document Development: Developing and reviewing process-related documents (e.g., protocols, procedures, manufacturing batch records)
  • Specifications Management: Preparing and updating specifications related to NPI materials and consumables
  • Operational Support: Providing operational technical support for process-related issue resolution
  • Experiment Design: Designing experiments to investigate new processes or failure modes
  • Training and Supervision: Supporting, supervising, and training operations personnel for SU processes
  • Compliance: Adhering to and supporting all EHS&E standards, procedures, and policies

Requirements:

  • Degree in science, engineering, or other relevant technical subject area
  • 2+ years direct experience in using single-use materials for biologics manufacturing in GMP environments
  • 1+ years experience in design, onboarding, and qualification of single-use assemblies for biologics manufacturing
  • Experience in client-facing roles collaborating with vendors and global stakeholders

This is an exciting opportunity to bring new products and technologies to the site.

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