Validation Specialist

4 weeks ago

Shannon, Ireland Blackfield Associates Full time

Overview
QC Validation Specialist
role at Blackfield Associates.
Location: UK & Ireland.
This is a permanent position from either the London or Ireland office.
The role supports the validation and transfer of analytical methods for cutting-edge gene therapy products within a GMP-regulated environment.
Key Responsibilities
Develop, validate, and transfer analytical methods.
Prepare validation protocols, reports, and SOPs in line with GMP and regulatory standards.
Support technology transfer and ensure compliance with EU/FDA guidelines.
Apply a range of analytical techniques (e.g. qPCR, HPLC, ELISA, Western blot, cell culture).
About You
Degree or MSc in Life Sciences or related field.
2+ years' experience in pharma/biologics or other regulated industry.
Strong background in analytical methods/validation, HPLC experience is required.
Knowledge of ICH Q2(R1), GMP, GDP, and data integrity.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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