Senior cGxP Laboratory Technician
RK1630
Dublin
Contract 6 months



The Senior cGxP Laboratory Technician plays a pivotal role in ensuring that all laboratory operations, infrastructure, and documentation align with global regulatory requirements and internal quality standards. This position serves as a subject matter expert (SME) in cGMP, GLP, and GDP compliance, driving continuous improvement across laboratory systems and practices.


Duties:

• Ensure all laboratory activities comply with global cGxP standards, internal SOPs, and applicable regulatory requirements.
• Lead compliance remediation programs and implement corrective and preventive actions (CAPAs) to address audit findings or process gaps.
• Maintain and update documentation systems, ensuring traceability, data integrity, and adherence to quality management principles.
• Oversee laboratory infrastructure maintenance, equipment qualification, calibration, and lifecycle management
• Drive standardization of laboratory processes to enhance efficiency, reliability, and reproducibility of analytical testing and support activities.
• Support change control, deviation management, and risk assessments related to laboratory operations.
• Provide technical guidance, coaching, and mentorship to junior laboratory staff to build compliance awareness and technical capability.
• Serve as a subject matter expert during internal and external audits, inspections, and quality reviews.
• Partner with Engineering, Validation, and Facilities to ensure proper integration of laboratory systems and support services.
• Collaborate with Quality Assurance on compliance strategy, document control, and audit preparation.
• Contribute to cross-site harmonization efforts and knowledge-sharing initiatives.
• Identify opportunities for process optimization, digitalization, and automation within the lab environment.
• Lead or participate in projects aimed at enhancing data integrity, efficiency, and compliance maturity.

• Bachelor’s degree (or higher) in a scientific discipline (e.g., Chemistry, Biology, Biomedical Engineering, or related field).
• Minimum of 5 years of experience in a regulated laboratory environment (medical device, pharmaceutical, or biotech).
• Deep understanding of cGxP principles and regulatory frameworks (FDA, ISO 13485, EMA, MHRA, etc.).
• Proven track record in remediation, audit readiness, and continuous improvement initiatives.