Validation Analyst

Randstad CPE; West Kirby; Sur place; GBP 42 000 - 60 000; Plein temps

Résumé du poste

Randstad CPE seeks an experienced Validation Analyst for a 12-month on-site contract in Liverpool. You will own method validation packages, conduct historical data reviews and robustness studies within a GMP environment.

Responsibilities include end-to-end analytical method validation (ICH Q2(R2), USP, Ph.), gap remediation, instrument/system validation reviews, and regulatory-compliant reporting. Suitable candidates have HPLC and wet chemistry expertise, data analysis skills, and LIMS

Qualifications

• Proven Industry Experience: Prior industrial laboratory experience in a regulated GMP environment (Pharmaceutical, Biopharma, Fine Chemicals, or Medical Devices/Healthcare).
• Analytical Validation Expertise: Demonstrated track record with analytical method validation, verification, and transfer protocols against ICH/pharmacopoeial standards.
• Laboratory Competencies: Strong working background in HPLC analysis and troubleshooting.
• Hands-on proficiency with wet chemistry techniques and standard laboratory instrumentation (e.g., UV-Vis, pH, conductivity, titrations).
• Data Management: Strong numerical analysis and data interpretation skills; intermediate-to-advanced proficiency in Microsoft Excel and the broader MS Office suite.
• Systems: Adaptable to learning proprietary in-house Laboratory Information Management Systems (LIMS) and quality management platforms.

Responsabilités

• Analytical Method Validation: Execute end-to‑end QC chemistry (and microbial, where applicable) method validation in compliance with ICH Q2(R2) , USP , and Ph.
• Eur. guidelines across both instrumentation and traditional wet chemistry techniques.
• Gap Remediation & Robustness: Address and close out identified technical gaps, including assessing method robustness and completing analytical remediation protocols.
• Historical Data Review: Conduct thorough historical QC method performance reviews and data validation assessments to bring analytical packages up to modern compliance standards (addressing multi-year data validation backlogs). System & Instrument Review: Support QC analytical instrument and data system validation reviews, ensuring data integrity and audit readiness.
• Technical Reporting: Compile, analyze, and present complex analytical validation data into clear, regulatory‑compliant reports and validation summaries.

Connaissances

Analytical method validation

Laboratory analysis

HPLC analysis

Wet chemistry techniques

Data interpretation

Instrument troubleshooting

Compliance awareness

Outils

Microsoft Excel

Laboratory Information Management System (LIMS)

MS Office Suite

Description du poste

Validation Analyst Contract Length: 12-Months Location: Liverpool, full time on site Pay rate: Negotiable Our client, a leading global healthcare and life sciences manufacturer, is seeking an experienced and proactive Validation Analyst to join their Quality Control team on an initial 12-month contract . This is a newly created, project-driven role established to tackle and close out critical validation and analytical gaps ahead of target deadlines in early 2027. You will take ownership of method validation packages, historical data reviews, and robustness studies across instrument and wet chemistry workflows within a strictly regulated GMP environment.

Key Responsibilities Analytical Method Validation: Execute end-to‑end QC chemistry (and microbial, where applicable) method validation in compliance with ICH Q2(R2) , USP , and Ph.

Eur. guidelines across both instrumentation and traditional wet chemistry techniques.

Gap Remediation & Robustness: Address and close out identified technical gaps, including assessing method robustness and completing analytical remediation protocols.

Historical Data Review: Conduct thorough historical QC method performance reviews and data validation assessments to bring analytical packages up to modern compliance standards (addressing multi-year data validation backlogs). System & Instrument Review: Support QC analytical instrument and data system validation reviews, ensuring data integrity and audit readiness.

Technical Reporting: Compile, analyze, and present complex analytical validation data into clear, regulatory‑compliant reports and validation summaries.

Requirements & Qualifications Essential Experience: Proven Industry Experience: Prior industrial laboratory experience in a regulated GMP environment (Pharmaceutical, Biopharma, Fine Chemicals, or Medical Devices/Healthcare). This role requires hands‑on experience and is not suitable for recent graduates.

Analytical Validation Expertise: Demonstrated track record with analytical method validation, verification, and transfer protocols against ICH/pharmacopoeial standards.

Laboratory Competencies: Strong working background in HPLC analysis and troubleshooting.

Hands‑on proficiency with wet chemistry techniques and standard laboratory instrumentation (e.g., UV-Vis, pH, conductivity, titrations). Data Management: Strong numerical analysis and data interpretation skills; intermediate‑to‑advanced proficiency in Microsoft Excel and the broader MS Office suite.

Systems: Adaptable to learning proprietary in‑house Laboratory Information Management Systems (LIMS) and quality management platforms.