CQV (Commissioning, Qualification, and Validation) Engineer

Location- PAN India, Base location- Bangalore (Malaysia, Singapore)

Experience- 3-8 Years

Industry: Pharma / Biotech / Life Sciences / Engineering

Role Overview

We are seeking a detail-oriented CQV Engineer to execute and manage Commissioning, Qualification, and Validation (CQV) activities for equipment, utilities, and systems. The role involves ensuring compliance with GxP guidelines, regulatory standards, and project requirements, along with delivering high-quality documentation and technical support at client sites.

Key Responsibilities

1) CQV Execution & Documentation

1. Prepare, review, and execute validation documents: URS, DQ, FAT/SAT, IQ, OQ, PQ protocols, and summary reports
2. Perform commissioning and qualification activities as per project timelines
3. Ensure data integrity, traceability, and compliance in all documentation
4. Participate in risk assessments, deviation handling, and change control processes
5. Develop test scripts and acceptance criteria for mechanical, electrical, and automation systems
6. Ensure systems meet design and regulatory requirements before GMP release

2) Compliance & Quality

1. Ensure adherence to GMP, GxP, and GDP standards
2. Follow regulatory guidelines such as ISPE, ASTM E2500, EU Annex 15, 21 CFR Part 11
3. Support internal/external audits by providing required documentation
4. Maintain accurate, audit-ready documentation
5. Contribute to continuous improvement initiatives

3) Client & Project Coordination

1. Act as a technical SPOC for assigned systems
2. Collaborate with QA, Engineering, Manufacturing, and Facilities teams
3. Coordinate with vendors and contractors during commissioning activities
4. Track and report project progress, risks, and deviations
5. Ensure compliance with EHS and client requirements

Required Skills

1. CQV (Commissioning, Qualification & Validation)
2. GMP / GxP / GDP compliance
3. IQ, OQ, PQ, FAT, SAT execution
4. Risk assessment & change control
5. Documentation & data integrity
6. Strong communication and stakeholder management

Qualification

1. B.E / B.Tech in Mechanical / Electrical / Instrumentation / Chemical / Biotechnology
2. Relevant certification in validation (preferred)

Preferred Experience

1. Pharma / Biotech / Life Sciences domain
2. Exposure to HVAC, cleanroom, utilities, or process equipment validation
3. Experience in Computer System Validation (CSV) is a plus