Validation Analyst - #2183708

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.

Desirable / Advantageous:

• Experience with Atomic Absorption (AA) spectroscopy.
• Working knowledge or background in microbiological methods (e.g., Total Viable Count [TVC], Bacterial Endotoxin Testing [BET/LAL], and microbial identification).
• Direct experience writing validation master plans, deviations, and CAPAs within quality management systems.

Key Attributes

• Self-Starter: Proven ability to work autonomously with minimal supervision, taking full ownership of project timelines and deliverables.
• Target-Driven: Highly organized with a focus on meeting defined milestone deadlines (March 2027 project cycle).
• Meticulous Attention to Detail: High standard of documentation hygiene and adherence to Good Documentation Practices (GDP) / Data Integrity standards.
• Collaborative: Able to integrate seamlessly into a small, focused technical team while driving independent workloads.