The QC Instrumentation Validation Engineer will be responsible for the qualification of laboratory instruments and systems used in Quality Control. The role ensures all QC equipment is installed, qualified and maintained in compliance with GMP and regulatory standards.
Responsibilities
:
* Prepare and execute IQ/OQ/PQ protocols for QC instrumentation (e.g. HPLC, GC, UV, TOC, dissolution testers).
* Perform calibration and validation activities, ensuring data integrity and compliance.
* Collaborate with QC, engineering and validation teams during equipment installation and qualification.
* Generate and maintain validation documentation, including deviations and change controls.
* Provide subject matter expertise during audits and inspections.
Requirements
:
* Degree in Science, Engineering or a related discipline.
* 2–5 years' experience in QC instrumentation validation in a GMP-regulated environment.
* Strong knowledge of laboratory equipment qualification and calibration practices.
* Familiarity with USP/EP, ICH, EMA and FDA requirements.
* Excellent documentation, organisational and communication skills.