SR.CQV Engineer

We are seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities for a greenfield biopharmaceutical manufacturing facility.

Key Responsibilities

• Execute Commissioning, Qualification & Validation (CQV) activities for GMP manufacturing systems and equipment.
• Develop and execute FAT/SAT, commissioning, IQ, OQ, and PQ protocols.
• Support equipment qualification for process, utility, and manufacturing systems.
• Review engineering/design documentation and ensure compliance with GMP requirements.
• Manage deviations, discrepancies, punch-list items, and qualification documentation.
• Coordinate CQV activities with Engineering, Automation, CSV, Quality, and Manufacturing teams.
• Support risk assessments, traceability, change control, and validation summary reports.
• Ensure qualification activities remain aligned with project schedules and GMP requirements.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or related technical field.
• 3-5 years of CQV experience in GMP-regulated pharmaceutical or biopharmaceutical environments.
• Experience with FAT/SAT, IQ/OQ/PQ, commissioning, and equipment qualification .
• Knowledge of GMP, validation principles, risk assessments, and change control.
• Experience working on greenfield or major capital projects preferred.
• Strong documentation, communication, and cross-functional coordination skills.