Operational Efficiency Specialist

2 weeks ago

Cork, Cork, Ireland beBeeOperationalEfficiency Full time €60,000 - €80,000

Operational Efficiency Specialist

About the Role

Catalyx seeks a highly skilled Operational Efficiency Specialist to join our team and work closely with customers in Cork. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

Responsibilities
  • Lead and execute qualification activities for process control and packaging serialization systems.
  • Develop and manage validation deliverables including URS, FS, DS, Risk Assessments, IQ/OQ/PQ protocols, and final reports.
  • Ensure that validation activities comply with site procedures, GMP regulations, and industry best practices (GAMP 5, FDA 21 CFR Part 11).
  • Provide subject matter expertise for equipment and automation-related validation issues, including deviation resolution and change control.
  • Participate in FAT, SAT, commissioning, and system handover processes for Delta V and serialization systems.
Requirements
  • Experience in equipment/system qualification or CSV roles in a GMP environment.
  • Previous exposure to Serialization systems in packaging environments is highly desirable.
  • Demonstrated ability to work independently and deliver in fast-paced, project-driven environments.
  • Experience in authoring and executing qualification documents (URS, FS, DS, IQ, OQ, PQ).
  • Excellent communication and stakeholder management skills.
Why Catalyx?

We take care of our people, offering great personal benefits and professional growth opportunities.

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