GMP Validation Engineer – Cleanrooms & HVAC (Home-Based)

CY Partners; Greater London; Remote; GBP 50,000 - 70,000; Full time

Job summary

CY Partners is seeking an experienced GMP Validation Engineer to support a diverse portfolio of life sciences and healthcare projects on a home-based basis across the UK. You will lead qualification activities for HVAC systems, cleanrooms, autoclaves and critical utilities, and develop validation documentation from URS through to final reports.

You will review designs, perform risk assessments and ensure compliance with cGMP and MHRA guidance while collaborating with clients, engineers and

Qualifications

• Hands-on GMP facilities validation experience.
• HVAC qualification and cleanroom validation experience.
• Ability to prepare validation protocols and technical documentation.

Responsibilities

• Lead qualification activities for HVAC systems, cleanrooms, autoclaves and critical GMP utilities.
• Perform cleanroom qualification including environmental monitoring, airflow, pressure differentials, HEPA filter integrity and contamination control assessments.
• Develop and execute validation documentation, including URS, VMP, DQ, IQ, OQ and Validation Summary Reports.
• Review facility designs, engineering specifications and technical documentation.
• Conduct quality risk assessments and supporting cross-contamination control strategies.
• Support projects from design and commissioning through to qualification and handover.
• Work with clients, designers, contractors and multidisciplinary engineering teams to ensure successful project delivery.
• Ensure compliance with cGMP, MHRA guidance and relevant regulatory requirements.

Skills

GMP validation

HVAC qualification

Cleanroom validation

Pharmaceutical equipment

Project management

Job description

CY Partners is seeking an experienced GMP Validation Engineer to support a diverse portfolio of life sciences and healthcare projects on a home-based basis across the UK. You will lead qualification activities for HVAC systems, cleanrooms, autoclaves and critical utilities, and develop validation documentation from URS through to final reports.

You will review designs, perform risk assessments and ensure compliance with cGMP and MHRA guidance while collaborating with clients, engineers and