EQUIPMENT VALIDATION ENGINEER

We are seeking an experienced Equipment Validation Engineer to support equipment qualification of two (2) incubators within a GMP-regulated biologics manufacturing facility, including validation of any associated computer system used for monitoring or data logging.

Key Responsibilities

- Author and execute Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols for two (2) incubators.

- Verify installation against vendor specifications and utility requirements (power, CO2 supply where applicable).

- Execute functional testing of temperature (and CO2, where applicable) setpoint accuracy, alarm functions (high/low temperature, door-open, power failure) and safety interlocks.

- Plan and execute temperature (and CO2, where applicable) uniformity mapping studies across empty and loaded/worst-case configurations, including door-open recovery testing.

- Support calibration verification and coordinate with metrology/calibration vendors as required.

- Support computer system validation (CSV) of any integrated data-logging or environmental monitoring system (EMS) associated with the incubators, including GAMP 5 categorization and 21 CFR Part 11 assessment (audit trail, e-signatures, data integrity).

- Raise, investigate and close protocol deviations, and manage redlines through to final qualification reports.

- Prepare and maintain qualification documentation, mapping study reports and validation summary reports.

- Coordinate with Engineering, Quality and Manufacturing/Lab stakeholders throughout the qualification lifecycle.

Requirements

Experience & Knowledge: Minimum 2-4 years hands-on experience in equipment qualification (IQ/OQ/PQ), including thermal/CO2 mapping studies, within a GMP-regulated pharmaceutical, biopharmaceutical or laboratory environment Degree or diploma in Biotechnology, Life Sciences, Engineering or a related technical discipline CSV exposure for environmental monitoring or data-logging systems is advantageous.

Technical Competencies: Practical experience authoring and executing IQ/OQ/PQ protocols and mapping studies familiarity with temperature/CO2 mapping methodology and equipment (data loggers, thermocouples) understanding of GAMP 5 and 21 CFR Part 11 requirements where CSV applies comfortable working with calibration and metrology processes.

Soft Skills: Strong technical writing and documentation discipline methodical, detail-oriented approach to protocol execution and data review effective communicator able to coordinate across Engineering, Quality and Lab/Manufacturing teams.

Adaptability: Able to work onsite within a live GMP environment and manage multiple concurrent mapping studies against a qualification schedule.