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 transfer and process validation activities.
- Perform change control, deviation management, and CAPA investigations related to CQV activities.
- Train and mentor junior engineers in CQV best practices.
- Collaborate with vendors and contractors for FAT/SAT and system handover.
- Prepare final turnover packages (TOPs), ensuring complete, traceable documentation.

Core Skills & Competencies:

- Strong expertise in IQ/OQ/PQ protocol development and execution.
- In-depth knowledge of cGMP, GAMP 5, ASTM E2500, ISPE guidelines, and regulatory requirements.
- Hands-on experience in commissioning and qualification of cleanrooms, HVAC, water systems, autoclaves, isolators, and critical utilities.
- Experience in automation systems (DCS/PLC/SCADA) qualification.
- Ability to lead CQV teams and manage multiple projects simultaneously.
- Excellent documentation, problem-solving, and analytical skills.
- Strong stakeholder communication and vendor management.

Qualification:

- Bachelor's or Master's degree in Engineering (Mechanical, Electrical, Chemical, Biomedical, or related).
- 10+ years of proven CQV experience in pharma/biotech/medical devices.
- Prior experience in large-scale greenfield/brownfield projects is highly desirable.

Core Highlights:

- 10+ years CQV in pharma/biotech/med devices
- Expert in IQ/OQ/PQ protocols & execution
- Strong knowledge of cGMP, ISPE, ASTM E2500, GAMP 5
- Commissioning of cleanrooms, utilities, process equipment, and automation systems
- Leadership in CQV strategy, risk-based approaches, and compliance
- Vendor, cross-functional, and project management skills

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