Job Title: Laboratory Validation Engineer
Position Overview
My client is seeking a Lab Validation Engineer to ensure GMP compliant validation of laboratory systems, instruments, and analytical methods supporting sterile/solid dose manufacturing. You'll own validation deliverables end to end risk assessment, planning, execution, and close-out driving right-first-time results and inspection readiness.
Key Responsibilities
* Lead validation lifecycle for lab equipment and systems (e.g., HPLC/UPLC, GC, dissolution, balances, incubators, LIMS, Empower/Chromeleon), including URS, risk assessments (FMEA), IQ/OQ/PQ, and periodic review.
* Execute and/or author analytical method validation plans and reports per ICH Q2(R2) (where applicable to role/scope).
* Deliver CSV/CSA for lab informatics in line with 21 CFR Part 11, EU Annex 11, GAMP 5, including data flows, access controls, audit trails, and backup/restore.
* Generate and maintain validation documentation: VMPs, protocols, scripts, traceability matrices, deviations, CAPAs, and final summary reports.
* Partner with QC, QA, IT, Engineering, and suppliers to plan qualifications, schedule downtime, and remediate issues.
* Ensure data integrity (ALCOA+) and inspection readiness; support MHRA/FDA/Notified Body audits and customer audits.
* Lead change control impact assessments; perform gap assessments for new instruments, software upgrades, and method transfers.
* Train lab users on validated states, SOPs, and good documentation practices.
* Drive continuous improvement to reduce validation cycle time while maintaining compliance (CSA risk-based approach).
Requirements
* Degree in a scientific/engineering discipline (Chemistry, Pharmaceutical Science, Biomedical Engineering, or related).
* Proven experience in GxP lab validation within a pharmaceutical/biotech or medical device environment.
* Hands-on equipment qualification (IQ/OQ/PQ) and/or computer systems validation for lab instruments and informatics.
* Strong knowledge of GMP, GAMP 5, EU GMP Annex 11/15, 21 CFR Part 11, Data Integrity principles.
* Excellent protocol/report writing, deviation/CAPA management, and stakeholder communication.
Looking forward to speaking with you!