validation Engineer (HVAC/Thermal)

Incepbio Pvt Ltd; Bengaluru; Presencial; INR 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

Incepbio Pvt Ltd in Bengaluru seeks a Validation Engineer to execute IQ, OQ, and PQ activities for cleanrooms and HVAC systems, ensuring regulatory alignment. You will collect data, analyze results, and document findings to support compliant validation campaigns.

You will troubleshoot issues, prepare reports, and collaborate with engineering, quality assurance, and production teams to drive continuous improvement and adherence to FDA/GMP/ISO standards.

Formación

• Must have hands-on experience with validation activities for cleanrooms and HVAC systems.
• Familiar with IQ/OQ/PQ protocols and risk-based validation approaches.
• Experience documenting results and generating regulatory-compliant reports.

Responsabilidades

• Perform validation activities including IQ, OQ, PQ for cleanrooms and HVAC systems.
• Collect and analyze data, ensuring complete documentation of results.
• Prepare validation reports and ensure compliance with FDA, GMP and ISO standards.
• Collaborate with engineering, quality assurance and production to coordinate validation.
• Identify and implement process improvements within validation activities.

Conocimientos

IQ/OQ/PQ validation

Data analysis

Documentation

Regulatory compliance

Cross-functional collaboration

Troubleshooting

Educación

Bachelor's or related field

Herramientas

MS Excel

Quality management systems

Descripción del empleo

• Perform validation activities: Execute validation protocols for cleanrooms and HVAC systems, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities.
• Data collection and analysis: Collect and analyze data during validation activities, ensuring accurate and complete documentation of results.
• Documentation and reporting: Prepare validation reports and documentation in compliance with regulatory requirements and internal procedures.
• Troubleshooting: Identify and troubleshoot issues related to cleanrooms and HVAC systems during validation activities and propose appropriate corrective actions.
• Compliance: Ensure compliance with regulatory guidelines (such as FDA, GMP, and ISO standards) and internal quality systems during validation activities.
• Collaboration: Work closely with cross-functional teams, including engineering, quality assurance, and production, to coordinate validation activities and resolve any issues or discrepancies.
• Continuous improvement: Identify opportunities for process improvement within the validation activities and contribute to the implementation of best practices.

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