LIMS Analyst

Careerwise Recruitment; Waterford; On-site; EUR 74,000 - 101,000; Part time

Job summary

Careerwise Recruitment is seeking a LIMS Analyst for a 12-month contract based in Waterford. The role covers Microbiology and Chemistry Labs, driving data integrity across digital workflows and implementing automation within the LIMS environment.

The ideal candidate will have 5+ years in a regulated lab, hands-on Thermo Sample Manager experience, and a strong grasp of DI principles and regulatory frameworks. This position focuses on validation, audits, and continuous improvement in a GMP setting.

Qualifications

• 5+ years of professional experience in a regulated laboratory environment (pharmaceutical, biotech, or medical device).
• Hands-on experience with Thermo Sample Manager LIMS, including configuring LIMS analyses and executing QC equipment integration.
• Strong understanding of Data Integrity (DI) principles, ALCOA+ concepts, and regulatory frameworks (FDA/EMA/cGMP) as applied to computerized systems.

Responsibilities

• Retrospectively update and refine existing LIMS analyses for Microbiology and Chemistry labs to maximize system efficiency.
• Implement and optimize LIMS automation features, including automated calculations, streamlined reporting, and dashboard development.
• Drive the end-to-end automation of interfaces between Quality Control (QC) laboratory equipment and the LIMS platform.
• Collaborate closely with internal lab stakeholders and external LIMS suppliers to deliver technical enhancements.
• Ensure all LIMS configurations, data flows, and computerised systems comply with current regulatory standards and company data integrity policies.
• Oversee the validation of computerized systems and LIMS updates to guarantee strict adherence to data integrity requirements.
• Identify and assess DI-related risks, investigate incidents or potential breaches, and implement effective Corrective and Preventive Actions (CAPA).
• Maintain continuous inspection readiness, participate in internal and external audits, and proactively remediate findings.
• Generate and review data integrity reports and metrics for management, specifically tracking the Data Integrity Maturity Model (DIMM).
• Represent the Waterford site in the Community of Practice (CoP) led by global teams, and participate in the Center of Excellence (CoE) as required.
• Identify site training needs, develop comprehensive training content on data integrity principles, and advise on cross-departmental DI strategies.

Skills

LIMS (Thermo SM)

Data Integrity

Regulatory compliance

Automation

QA/QC

Tools

Thermo Sample Manager LIMS

QC equipment integration

Job description

Our client who is a leading manufacturing company has a requirement for a LIMS Analyst .This is a 12 month contracting position based in Waterford. This is specifically for the Microbiology and Chemistry Laboratories while ensuring robust Data Integrity is embedded across all digital workflows.

Responsibilities

• Retrospectively update and refine existing LIMS analyses for Microbiology and Chemistry labs to maximize system efficiency.
• Implement and optimize LIMS automation features, including automated calculations, streamlined reporting, and dashboard development.
• Drive the end-to-end automation of interfaces between Quality Control (QC) laboratory equipment and the LIMS platform.
• Collaborate closely with internal lab stakeholders and external LIMS suppliers to deliver technical enhancements.
• Ensure all LIMS configurations, data flows, and computerised systems comply with current regulatory standards and company data integrity policies.
• Oversee the validation of computerized systems and LIMS updates to guarantee strict adherence to data integrity requirements.
• Identify and assess DI-related risks, investigate incidents or potential breaches, and implement effective Corrective and Preventive Actions (CAPA).
• Maintain continuous inspection readiness, participate in internal and external audits, and proactively remediate findings.
• Generate and review data integrity reports and metrics for management, specifically tracking the Data Integrity Maturity Model (DIMM).
• Represent the Waterford site in the Community of Practice (CoP) led by global teams, and participate in the Center of Excellence (CoE) as required.
• Identify site training needs, develop comprehensive training content on data integrity principles, and advise on cross-departmental DI strategies.

Qualifications & Experience

• 5- + years of professional experience in a regulated laboratory environment (pharmaceutical, biotech, or medical device).
• Hands-on experience with Thermo Sample Manager LIMS, including configuring LIMS analyses and executing QC equipment integration.
• Strong understanding of Data Integrity (DI) principles, ALCOA+ concepts, and regulatory frameworks (FDA/EMA/cGMP) as applied to computerized systems.