Senior CQV Engineer

3 weeks ago

Vijayawada, Andhra Pradesh, India Tek Support Full time

Job Title: Senior CQV Trainer

Location: Vijayawada, IND

Employment type: Part-time

Job Summary:

We are seeking a highly experienced Commissioning & Qualification (CQV) Trainer with 10+ years in the pharmaceutical, biotech, or medical device industries. The role involves leading and executing CQV activities for facilities, utilities, equipment , and systems to ensure compliance with regulatory standards (FDA, EMA, cGMP, ICH, ISPE guidelines) . The candidate will be responsible for managing end-to-end commissioning, qualification, and validation processes to support product development and commercial manufacturing.

Responsibilities:

Lead CQV strategy and execution for capital projects, including facility, utility, process equipment, and automation systems. Prepare and review C&Q documentation : URS, FAT, SAT, IQ, OQ, PQ protocols, test scripts, and final reports. Ensure compliance with cGMP, FDA, EMA, ISPE Baseline Guides, ASTM E2500, and ICH guidelines. Oversee commissioning activities : system walkdowns, punch-list management, testing, and issue resolution. Manage cross-functional teams (Engineering, QA, Validation, Operations, Automation). Develop and implement risk-based approaches (RBV/CQV). Support technology

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