Senior GxP Validation Specialist

MeiraGTx; City Of London; On-site; GBP 50,000 - 70,000; Full time

Job summary

A biotechnology company in the UK is seeking a seasoned engineering validation professional to ensure compliance with GxP regulations and provide support across various processes and systems. The ideal candidate will have at least 5 years of experience in Engineering Validation with a focus on Computer System Validation. Responsibilities include overseeing validation documentation and serving as a subject matter expert during inspections.

Qualifications

• 5+ years experience in Engineering Validation focusing on Computer System Validation.
• Knowledge of GxP regulations and guidelines.
• English language proficiency required.

Responsibilities

• Provide ongoing engineering validation support for GxP processes.
• Ensure compliance with EU, UK, and FDA regulations.
• Review qualification protocols and discrepancies in a timely manner.

Skills

Experience with GxP regulations

Problem-solving skills

Effective communication

Ability to manage change

Fast-paced adaptability

Education

Degree in Human Health or Sciences

Job description

A biotechnology company in the UK is seeking a seasoned engineering validation professional to ensure compliance with GxP regulations and provide support across various processes and systems. The ideal candidate will have at least 5 years of experience in Engineering Validation with a focus on Computer System Validation. Responsibilities include overseeing validation documentation and serving as a subject matter expert during inspections.