validation Engineer (HVAC/Thermal)

IncepBio Private Limited; Bengaluru; Presencial; INR 600.000 - 900.000; Jornada completa

Descripción de la vacante

IncepBio Private Limited in Bengaluru, Karnataka, seeks a Validation Specialist to execute IQ/OQ/PQ protocols for cleanrooms and HVAC systems, collect data, and prepare compliant validation reports.

You will troubleshoot issues, ensure FDA/GMP/ISO compliance, collaborate with engineering, QA, and production, and contribute to continuous process improvements.

Responsabilidades

• 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.

Descripción del empleo

Responsibilities:

• 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.