System Lead

2 days ago

Dundalk, Louth, Ireland beBeeManufacturing Full time €60,000 - €85,000
Manufacturing Systems Specialist

We are seeking a skilled professional to lead our Manufacturing Systems team.

  • Job Summary: The successful candidate will be responsible for establishing and leading the Manufacturing Systems team, ensuring the effective management of manufacturing processes and systems.

Key Responsibilities:

  1. Provide expert support to the manufacturing team in areas such as SAP, LIMS, finite scheduling, and benchtop equipment.
  2. Process and system owner for Manufacturing benchtop equipment, ensuring management of vendors, maintenance of accurate equipment lists, and adherence to required system SOPs.
  3. Collaborate with relevant departments on all aspects of benchtop equipment qualification lifecycle, from URS to decommissioning.
  4. Coordinate vendor visits on site for benchtop support, qualification, and maintenance as needed.
  5. Ensure GMP compliance by managing deviation investigation and CAPA implementation, supporting client auditing and agency inspections, and collaborating with QC & QA groups.

Requirements:

  • Educational background in Chemical Engineering, Bioscience, Biotechnology, or Analytical Science.
  • At least 2 years of experience in biopharmaceutical manufacturing, including experience with GMP systems like SAP and benchtop equipment qualification and operation.
  • Strong understanding of quality systems, including deviation, investigation, CAPA, and change control.
  • Excellent communication and presentation skills, with the ability to work effectively with staff at all levels.

About this role:

This is an exciting opportunity to join a dynamic team and contribute to the success of our organization. If you have a passion for manufacturing systems and a strong track record of achievement, we encourage you to apply.

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