Validation Engineer

4 weeks ago


Hyderabad, Telangana, India TekOne IT Services Pvt. Ltd. Full time

CQV Engineer (Commissioning, Qualification, and Validation Engineer) - H1B Sponsorship

Job Description:

A CQV Engineer is responsible for ensuring that the equipment, systems, and processes used in manufacturing and production environments are validated and commissioned properly according to industry standards. They ensure that equipment meets its intended purpose and functions as expected, ensuring regulatory compliance (such as FDA, ISO standards). The CQV process includes checking, testing, and documenting all activities associated with equipment validation.

Key Responsibilities:

  • Perform commissioning and qualification of equipment and systems.
  • Prepare and execute IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols.
  • Develop and manage documentation for validation activities, including reports and procedures.
  • Ensure compliance with cGMP (current Good Manufacturing Practices), FDA, and other relevant regulatory bodies.
  • Troubleshoot issues and perform corrective actions when deviations are detected.
  • Collaborate with engineering teams to optimize processes and equipment performance.

Skills:

  • In-depth knowledge of validation processes and protocols.
  • Experience with cGMP, FDA regulations, and other industry standards.
  • Strong understanding of process and equipment qualification.
  • Excellent documentation and report-writing skills.
  • Problem-solving skills for troubleshooting equipment or systems issues.
  • Knowledge of control systems and automation (e.g., SCADA, PLC).
  • Familiarity with risk management and validation lifecycle.

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