Computer System Validation/Lab Systems Validation Analyst

Computer System Validation/Lab Systems Validation Analyst - 3 months + €500-540pd - Meath Ireland

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 life cycle. 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 (eg, CDS, LIMS, ELN, SDMS).
• Author, review, and approve validation deliverables (eg, 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.

Damia Group Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept our Data Protection Policy which can be found on our website.

Please note that no terminology in this advert is intended to discriminate on the grounds of a person's gender, marital status, race, religion, colour, age, disability or sexual orientation. Every candidate will be assessed only in accordance with their merits, qualifications and ability to perform the duties of the job.

Should the role require the successful candidate to undergo and be eligible for UK Security Vetting. Clearance sponsorship will be provided where required. Due to the nature of the work, candidates should meet the relevant residency requirements. If applicable, Reserved Post nationality restrictions will be confirmed by the client. Damia is committed to inclusive recruitment and welcomes applicants from all backgrounds.

Damia Group is acting as an Employment Business in relation to this vacancy and in accordance to Conduct Regulations 2003.