Single-Use Materials Specialist

18 hours ago

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

**Job Title:** Process Scientist

We are seeking a highly skilled and experienced Process Specialist to join our Technical Operations Team in Sligo. The successful candidate will work closely with site cross-functional teams and global science and quality teams on the development and evolution of single-use materials used in biologics manufacturing processes.

Responsibilities:
  • Work closely with site cross-functional team and global science and quality teams on the development and evolution of single-use materials used in biologics manufacturing processes.
  • Lead and/or assist risk assessments for the introduction or modification of product path including single-use materials (e.g., pFMEA, SU RA, E&L assessment) including required change management activities.
  • Interact with manufacturers and vendors on best practices and validation packages, and function as technical lead for SU complaints.
  • Assist with the development of manufacturing process for new products including developing and/or reviewing process-related documents e.g., Protocols/ Procedures/ Manufacturing Batch Records.
  • Prepare and update specifications related to NPI materials and consumables, including single-use materials used in the product path.
  • Provide operational technical support for process-related issue resolution, design experiments to investigate new processes or failure modes, assist and/or lead single-use process-related investigations.
  • Monitor and analyze process data during the manufacturing.
  • Support, supervise, and train operations personnel for SU processes.
  • Adhere to and support all EHS&E standards, procedures, and policies.
Requirements:
  • Degree in science, engineering, or other relevant technical subject area.
  • 2+ years direct experience in the use of single-use materials for biologics manufacturing in GMP environment e.g., in operations, technical operations, and process validation.
  • 1+ years experience in the design, onboarding, and qualification of single-use assemblies for biologics manufacturing.
  • Experience in client-facing role collaborating with vendors and global stakeholders.

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