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Instrumentation Systems Maintenance Specialist

2 weeks ago

Dublin, Dublin City, Ireland Psc Biotech Corporation Full time
Role Overview
PSC Biotech Corporation is a leading biotech consultancy firm seeking a highly skilled Instrumentation Systems Maintenance Specialist. This role plays a vital part in maintaining the testing infrastructure of our Quality Control (QC) lab, ensuring all materials used for our products meet our high standards of quality and regulatory requirements. The successful candidate will have strong experience in CSV and/or CQV for laboratory systems and instrumentation.

Key Responsibilities
- Qualify, maintain, and integrate QC systems in compliance with data integrity, regulatory, and industry standards.
- Support troubleshooting, investigations, and deviations as an SME and manage CAPAs and change controls related to QC and team priorities.
- Assist with implementing client Quality Chapters to ensure best practices and build excellence into our QC systems and processes.

Requirements
- Bachelor's degree in Engineering or a related field.
- 3 years' experience in CSV and/or CQV for laboratory systems and instrumentation. Experience in regulatory audits and working knowledge of biologics analytical methods and specifications, Good Manufacturing Practice (GMP), and data integrity compliance requirements.
- Strong organizational, problem-solving, and continuous improvement skills.