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Process Materials Specialist

3 weeks ago

Sligo, Sligo, Ireland beBeeBiologics Full time €55,000 - €85,000
Job Description

We are seeking an expert in the field of biologics manufacturing to join our technical operations team. The successful candidate will be responsible for the development and evolution of single-use materials used in the product path.

This role reports directly to the NPI Technical Manager and offers an exciting opportunity to contribute to the growth and innovation of our company.

The ideal candidate will possess strong collaboration skills, initiative-taking abilities, and the capacity to work under strict project timelines.

Key Responsibilities:
  • Work closely with cross-functional teams and global science and quality teams on the development and evolution of single-use materials.
  • Lead and assist risk assessments for the introduction or modification of product paths, including single-use materials.
  • Interact with manufacturers and vendors on best practices and validation packages, serving as a technical lead for SU complaints.
  • Assist with the development of manufacturing processes for new products, developing and reviewing process-related documents.
  • Prepare and update specifications related to NPI materials and consumables.
  • Provide operational technical support for process-related issue resolution, design experiments to investigate new processes or failure modes.
  • Monitor and analyze process data during manufacturing.
  • Support, supervise, and train operations personnel for SU processes.
Qualifications

The successful candidate should hold a degree in a relevant scientific or engineering subject area and have 2+ years of direct experience in the use of single-use materials for biologics manufacturing in a GMP environment.

Additionally, they should possess 1+ year of experience in the design, onboarding, and qualification of single-use assemblies for biologics manufacturing, as well as experience in client-facing roles collaborating with vendors and global stakeholders.