We are looking for a Validation Engineer to support a range of qualification and validation activities across critical equipment and controlled environments. This role involves the execution of temperature mapping, equipment validation, protocol development, and performance verification to ensure compliance with regulatory standards and internal quality systems.
Key Responsibilities:
- Temperature Mapping & Environmental Qualification:
- Conduct thermal mapping studies for Cold Rooms (2°C to 8°C), Freezers, and Incubators using Kaye AVS (Advanced Validation System).
- Prepare and execute IOPQ protocols, perform data analysis, and compile comprehensive validation summary reports.
Autoclave Validation:
- Manage requalification of site autoclaves and qualification of new units, ensuring alignment with cGMP standards.
- Support introduction of new loads such as towel packs and perform specialized tests like the Air Detector Test.
- Develop and execute SOPs, OPQ protocols, and performance verification plans for all validated loads.
Equipment Validation:
- Validate and qualify Kaye Validator AVS systems through IOQ protocol development, execution, and reporting.
- Support calibration and maintenance of validation instrumentation and document performance accordingly.
Airflow Visualization Studies:
- Perform smoke studies (air visualization) for biosafety cabinets (BSCs), cleanroom zones, and equipment doors in compliance with cleanroom standards.
- Execute protocols and prepare clear and accurate documentation including study reports.
Documentation & Compliance:
- Draft validation documentation including protocols, deviation reports, and final summary reports.
- Identify and resolve discrepancies in validation findings, escalating issues as needed.
- Prepare and maintain validation maintenance reports for facility and equipment (F&E).
Requirements:
- Bachelor’s Degree or Diploma in Engineering, Life Sciences, or a related technical discipline.
- Solid experience in equipment qualification, environmental validation, and temperature mapping using Kaye AVS.
- Knowledge of regulatory standards including cGMP, GDP, and GxP.
- Strong understanding of validation lifecycle: IQ, OQ, PQ, and requalification.
- Excellent technical writing, data analysis, and problem-solving skills. Ability to work independently and collaboratively across functional teams.
Preferred Qualifications:
- Previous experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
- Familiarity with cleanroom validation and environmental monitoring standards.