Process Operations Specialist

1 day ago

Carlow, Ireland beBeePharmaceutical Full time €40,000 - €60,000

We are seeking a highly skilled specialist to support our process operations team.

Key Responsibilities:
  • The ideal candidate will assist in the creation and management of documentation for manufacturing activities, ensuring adherence to quality standards.
  • They will work closely with the MES development team to provide technical expertise on system functionality and serve as a subject matter expert within the IPT.
  • This role involves managing document systems, including review, approval, and workflow expedition, to maintain efficiency and compliance.
  • The selected candidate will be responsible for formatting, writing, delivering, and reviewing necessary documentation according to standard approval processes, as well as facilitating others to do so.
  • They will develop SOPs, SWIs, training documents, and change controls to ensure seamless implementation and maintenance of processes.
  • This position requires supporting operational activities through documentation generation, filing, tracking, auditing, and efficient maintenance of associated databases, including process documentation systems.
  • The successful candidate will ensure timely completion of Quality Notification requirements, generate interim/summary reports, and meet batch release needs.
  • They will identify and resolve system issues, implementing corrective action through the change management system.
Requirements:
  • A bachelor's degree or higher in a Science, Engineering, or Technical discipline is preferred.
  • The ideal candidate will have relevant experience and a skill set in their area of expertise, adding value to the business, ideally in manufacturing, preferably in a GMP setting.
  • SAP knowledge and experience are required, as well as proficiency in Microsoft Office and job-related computer applications.
  • The selected candidate should have knowledge of regulatory/code requirements for Irish, European, and International Codes, Standards, and Practices.
  • Strong report, standards, and policy writing skills are essential.
  • Experience with equipment and process validation, sterile filling processes and equipment, and Lean Six Sigma Methodology is desired.

This is an excellent opportunity to join a world-class pharmaceutical centre that develops and produces veterinary vaccines. The successful candidate will contribute to critical investment projects, working both on-site and remotely.

The pharmaceutical centre prioritizes innovation, collaboration, and excellence, providing a dynamic environment for growth and development. If you are a motivated and detail-oriented professional looking to make a meaningful contribution, we encourage you to apply for this challenging and rewarding role.

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