Validation Engineer

Job Purpose

The Validation Engineer develops and maintains validation strategies for lab systems, ensuring compliance with GLP, EMA Annex 11, FDA 21 CFR Part 11, and internal standards. The role leads validation activities, manages change control, collaborates with teams and vendors, and supports audits to ensure compliant, secure, and efficient laboratory operations.

Main Areas of Responsibility

• Develop and maintain the laboratory validation strategy and lifecycle for computerized and non-computerized systems aligned with GLP, EMA Annex 11, FDA 21 CFR Part 11, and internal quality standards.
• Lead and execute computerized systems validation (CSV) activities for laboratory IT systems and software (e.g., LabKey, MyAssay, electronic lab notebooks, instrument software, controlled Excel tools).
• Author, review, and approve validation documentation including URS, risk assessments, validation plans and reports, test scripts, traceability matrices, and SOPs
• Own and maintain change control processes for lab systems (hardware/software), ensuring risk-based evaluation, testing, documentation, and stakeholder approval prior to implementation.
• Manage supplier/vendor selection and assessment for lab hardware/software/service providers; maintain vendor scorecards and support audits.
• Design data flow diagrams to map data origins, transformations, storage, and backup across systems including MyAssay, LabKey, Excel, and archive tools.
• Collaborate with cross-functional teams (QA, IT, Scientists, Data Management, Regulatory Affairs) to support change control events, system deployment, and continuous improvements.
• Provide training and user support on SOPs, IT systems, and regulatory requirements related to validation
• Monitor regulatory developments, implement best practices, and drive efficiency improvements via test automation, reusable templates, and lifecycle planning.

Qualifications & Experience

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Computer Science, or related field.
• 3-5 years’ experience in computerized systems validation (CSV) within a regulated bioanalytical environment (GLP/GMP/GCP).
• Demonstrated experience with equipment qualification (IQ/OQ/PQ), data integrity validation (audit trails, e-signatures, backup/recovery), and regulatory frameworks (FDA 21 CFR Part 11, EMA Annex 11).
• Familiarity with LabKey, MyAssay, LIMS, and validation of Excel-based tools.
• Proven track record in supplier qualification, audit support, and documentation of validation processes

Desirable Skills & Attributes

• Excellent technical writing and documentation skills.
• Proficiency in data flow visualization tools (e.g., Visio).
• Knowledge of scripting or test automation tools (e.g., Python, SQL).
• Strong attention to detail, analytical skills, and ability to manage multiple priorities in a regulated setting.

PLEASE ENSURE THAT YOUR CV/RESUME IS SUBMITTED IN ENGLISH.