Lab System Validation Analyst
€450 - €530 a day
County Meath - Ireland
Job Summary:
We are seeking a detail-oriented and experienced Lab System Validation Analyst to support validation efforts for computerized laboratory systems in regulated (GxP) environments. This role is critical in ensuring lab systems meet regulatory requirements and perform reliably throughout their lifecycle. You'll work closely with QA, IT, and Lab Operations to plan, execute, and maintain validation deliverables.
Key Responsibilities:
Lead and execute computer system validation (CSV) activities for lab instruments, software, and analytical platforms (e.g., CDS, LIMS, ELN, SDMS).
Author, review, and approve validation deliverables (e.g., URS, FRS, RTM, IQ/OQ/PQ protocols, validation plans, and reports).
Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and relevant data integrity standards.
Support risk assessments and impact analyses for system changes and new implementations.
Partner with QA and Lab/IT stakeholders to define validation strategy, timelines, and resource needs.
Maintain the validated state of systems through periodic reviews, audit support, and change control.
Provide guidance and training to system owners and users on validation processes and regulatory requirements.
Participate in vendor audits and qualification efforts where required.
Required Qualifications:
Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
3+ years of experience in a GxP-regulated lab environment performing system validation or CSV.
Familiarity with lab informatics systems such as Waters Empower, Agilent OpenLab, LabVantage, MasterControl, etc.
Solid knowledge of regulatory requirements including GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles.
Experience with documentation and testing tools such as HP ALM, ValGenesis, or similar.
Preferred Skills:
Experience in pharmaceutical, biotech, or medical device environments.
Exposure to cloud-based lab systems and their validation considerations.
Understanding of lab workflows and instrument qualification (IQ/OQ/PQ).
Working knowledge of project management or SDLC methodologies (Agile, Waterfall).
Soft Skills:
Strong analytical thinking and attention to detail.
Excellent communication and documentation skills.
Ability to manage multiple priorities and collaborate across cross-functional teams