Validation Specialist

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!