Biotechnology Process Specialist

3 days ago

Dundalk, Louth, Ireland beBeeEngineering Full time €95,000 - €110,000

Job Title: Senior Process Engineer

Job Overview:

We are seeking a highly experienced Senior Process Engineer to join our Manufacturing Technology team. As a key member of this team, you will be responsible for providing engineering support to the ongoing requirements for manufacturing operations and supporting future technology transfer projects.

Main Responsibilities:
  • Assist in site start-up and project-related activities, ensuring seamless integration with existing systems.
  • Support package owners on vendor management and equipment or process-related activities and queries, providing expert guidance and recommendations.
  • Develop and implement equipment verification & validation protocols and reports as required, guaranteeing compliance with industry standards.
  • Review vendor documentation for completeness and accuracy, identifying areas for improvement and implementing changes.
  • Participate in Factory Acceptance Testing (FAT) and vendor-related activities, ensuring that all equipment meets quality and safety standards.
  • Support issue resolution during equipment installation, commissioning, and qualification phases, minimizing downtime and maximizing productivity.
Requirements:
  • Third-level qualification in a Science or Engineering related subject is highly desirable.
  • Minimum of 8 years experience in a large-scale biopharmaceutical/pharmaceutical facility, preferably in a leadership or senior technical role.
  • Excellent communication skills, including computer literacy and ability to work independently and in a team environment.
  • Thorough knowledge of current Good Manufacturing Practices (cGMP), with a strong understanding of regulatory requirements.
  • Experience and knowledge of DeltaV MCS platform is highly preferred.
  • Familiarity with Chromatography and Ultra filtration production operations is an advantage.

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