QA Validation Engineer

Description

Walker Cole International is currently supporting a leading pharmaceutical manufacturer in the recruitment of a QA Validation Engineer to join their team on a permanent basis.

The QA Validation Engineer will be responsible for the ongoing operation, validation, and continuous improvement of clean utility systems including Purified Water (PW), Water for Injection (WFI), Clean Steam, Compressed Air, and Process Gases, ensuring compliance with GMP and regulatory standards.

What the QA Validation Engineer will be doing:

Leading the operation and validation of clean utility systems, ensuring reliability and compliance.

Managing deviations, CAPAs, change controls, and documentation in line with GMP and regulatory standards.

Acting as a subject matter expert (SME) during audits and inspections.

Driving continuous improvement projects to enhance system performance and sustainability.

Collaborating with cross–functional teams to support production and facility operations.

What the ideal QA Validation Engineer will have:

Degree in Mechanical, Chemical, or Process Engineering (or related field).

Relevant experience working with clean utilities or validation in a GMP–regulated pharmaceutical or biotech environment.

Strong knowledge of clean utility systems and relevant standards (e.g., EU GMP Annex 1, USP, ISPE).

Experience with validation protocols, change control, and deviation investigations.

QA Validation Engineer Clean Utilities Water for Injection Purified Water Clean Steam GMP Pharmaceutical Manufacturing Validation Engineer Process Utilities Pharmaceutical Engineer CAPA Deviation Management Change Control Quality Assurance Compliance Regulatory ISPE EU GMP Annex 1 Utilities Validation

Ad ID: 5416842298