CSV Systems Specialist

2 weeks ago

Cork, Cork, Ireland beBeecsvspecialist Full time €60,000 - €80,000
Job Opportunity

We are seeking a skilled CSV Specialist to work on-site in Cork.

This is a high-impact role requiring immediate engagement in qualification activities and collaboration with Commissioning & Qualification (C&Q) and Automation teams.

The successful candidate will lead the full lifecycle of qualification activities for process control and packaging serialisation systems, ensuring compliance with site procedures and industry best practices.

Candidates should have experience in equipment/system qualification or CSV roles in a GMP environment. Previous exposure to Serialisation systems in packaging environments is highly desirable.

Key Responsibilities:
  • Develop validation deliverables including URS, FS, DS, Risk Assessments, IQ/OQ/PQ protocols, and final reports.
  • 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 serialisation systems.
  • Engage directly with project teams to ensure validation requirements are integrated into project planning and execution.
Requirements:
  • Excellent communication and stakeholder management skills.
  • Demonstrated ability to work independently and deliver in fast-paced, project-driven environments.

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