Job Description

Job Overview:

We are seeking a proactive and technically skilled

Cleanroom Validation Engineer

to join our service delivery team, providing cleanroom and controlled environment validation services to clients across the UK. The successful candidate will be responsible for performing environmental qualification and validation activities in line with current Good Manufacturing Practice (cGMP), ISO 14644, and other relevant regulatory guidelines. Experience in

instrument calibration

and

on-site client support

is highly desirable.

This is a client-facing, field-based role that requires strong technical knowledge, attention to detail, and a commitment to high standards of service and regulatory compliance. Salary will be determined by proven experience.

Key Responsibilities:

Cleanroom & Facility Validation

Perform cleanroom qualification and requalification (e.g. airborne particle counts, airflow visualisation, pressure differential testing, recovery rate testing, etc.). Carry out validation of controlled environments in line with ISO 14644, EU GMP Annex 1, and MHRA/FDA expectations. Generate and review validation documentation (protocols, reports, risk assessments, etc.).

Calibration Services

Perform calibration of instruments and equipment including temperature, humidity, pressure, etc. Maintain calibration records in line with UKAS/ISO 17025 or client-specific requirements. Support clients in maintaining compliant calibration schedules and systems.

Client Interaction & Service Delivery

Act as the technical point of contact on client sites, delivering a high standard of customer service. Prepare and present validation data and reports clearly and accurately. Advise clients on compliance gaps, remedial actions, and continuous improvement opportunities.

Quality & Compliance

Ensure all activities are carried out in accordance with company SOPs, client procedures, and applicable regulatory standards. Maintain up-to-date knowledge of relevant standards and guidelines (e.g. ISO 14644, Annex 1, ISO 17025). Support internal and external audits as required.

Key Skills & Qualifications:

Essential:

Technical or engineering qualification (HNC/HND/Degree) in a relevant field (Engineering, Life Sciences, etc.). Experienced candidates will also be considered. Experience in cleanroom validation or environmental monitoring. Strong understanding of ISO 14644 and cleanroom principles. Full UK driving licence and willingness to travel to client sites (often with overnight stays).

Desirable:

Experience in instrument calibration (pressure, temperature, humidity, etc.). Knowledge of UKAS accreditation or ISO 17025 standards. Experience working with clients in GMP-regulated industries (pharma, medtech, biotech, etc.). Familiarity with cleanroom airflow visualisation (smoke testing), HEPA filter integrity testing, and data loggers.

Personal Attributes:

Professional and confident communicator with excellent client-facing skills. Strong attention to detail and ability to follow complex procedures. Self-motivated and organised, with good time management. Flexible and willing to travel regularly.

Benefits:

Competitive salary plus overtime and travel allowances Bonus scheme Company vehicle Pension scheme Training and development opportunities (e.g. ISO/GMP training) Competitive holiday package Private Healthcare Supportive, team-focused culture

Additional Information:

This is a field-based role requiring regular travel across the UK. Applicants must be willing to stay away from home when required, sometimes at short notice.

Job Type: Full-time

Pay: From 35,000.00 per year

Benefits:

Private medical insurance
Work Location: On the road