GMP Validation Engineer – Cleanrooms, HVAC & Autoclaves

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

Location: Home-based, Southern UK Territory

Working Arrangements: Flexible working, with regular UK-wide travel

CY Partners is recruiting a GMP Validation Engineer on behalf of a specialist consultancy providing validation and technical support to pharmaceutical, laboratory, aseptic and healthcare environments.

This is an excellent opportunity for an experienced validation, CQV or commissioning professional with expertise in facilities, HVAC systems, cleanrooms and critical equipment qualification to work on a varied portfolio of projects across the life sciences and healthcare sectors.

Working with clients including NHS organisations, universities and leading research institutions, you will support projects from design and specification through to commissioning, qualification and final handover.

The Role

You will provide technical validation and qualification expertise across GMP-regulated facilities, systems, utilities and equipment.

Key responsibilities include:

• Leading and executing qualification activities for HVAC systems, cleanrooms, autoclaves, sterilisation equipment and critical GMP utilities.
• Undertaking cleanroom qualification, including environmental monitoring, airflow, pressure differentials, HEPA filter integrity and contamination control assessments.
• Developing and executing validation documentation, including URS, VMP, DQ, IQ, OQ and Validation Summary Reports.
• Reviewing facility designs, engineering specifications and technical documentation.
• Conducting quality risk assessments and supporting cross-contamination control strategies.
• Supporting projects from design and commissioning through to qualification and handover.
• Working with clients, designers, contractors and multidisciplinary engineering teams to ensure successful project delivery.
• Ensuring compliance with cGMP, MHRA guidance and relevant regulatory requirements.

About You

We are particularly interested in candidates with hands-on experience in GMP facilities validation, HVAC qualification, cleanroom validation or pharmaceutical equipment qualification.

Ideally, you will have:

• Practical experience qualifying HVAC systems, cleanrooms, utilities or critical pharmaceutical equipment.
• Knowledge of autoclaves, sterilisation systems, temperature mapping and equipment qualification.
• Understanding of cleanroom design, HEPA filtration, airflow, pressure cascades and contamination control.
• Experience preparing and executing validation protocols and technical documentation.
• Knowledge of GMP, quality risk management and relevant regulatory guidance.
• Strong project management, communication and stakeholder engagement skills.
• Willingness to travel regularly across the UK, including occasional overnight stays.

Experience with RIBA design stages, process gas qualification, AI technologies or coaching colleagues would also be advantageous.

Additional Information

This is a home-based role covering a Southern UK territory, with regular travel to client sites across the UK. Flexible working is available, with some flexibility around working hours to accommodate client commitments.

Interested?

If you have experience in GMP validation, cleanroom qualification, HVAC systems, autoclaves or pharmaceutical facilities and equipment, we would love to hear from you.

Whether your background is in validation, CQV, commissioning or pharmaceutical engineering, this is an opportunity to apply your expertise across a diverse range of specialist projects.

We look forward receiving your application!