ABOUT NO DEVIATION

At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That’s why we foster a culture of collaboration, inclusion, and continuous development empowering our team members to grow personally and professionally.

POSITION OVERVIEW

The CQV Engineer (Utilities Qualification) is responsible for the commissioning, qualification, and validation of critical utility systems such as Water for Injection (WFI), Purified Water, Clean Steam, Compressed Dry Air (CDA), HVAC, and other facility support systems. The role ensures that all systems are installed, tested, and qualified in compliance with cGMP, regulatory requirements, and project-specific standards.

REQUIRED QUALIFICATIONS

• Bachelors Degree in Engineering, Life Sciences, or related discipline
• 10 years experience in CQV for utilities systems in the pharmaceutical / biotech industry.
• Strong knowledge of GMP guidelines, USP/EP, ISPE Baseline Guides, ASTM E2500, and Annex 15.
• Hands-on experience with water systems, clean steam, compressed gases, and HVAC qualification.
• Familiarity with laboratory testing and monitoring equipment (TOC analyzers, conductivity meters, microbial sampling).
• Strong problem-solving, documentation, and stakeholder communication skills.
• Ability to work independently and as part of a cross-functional project team.

• Lead and execute commissioning and qualification activities for utilities (WFI, Purified Water, Clean Steam, CDA, HVAC, and related systems).
• Develop and execute lifecycle documents including URS, DQ, FAT, SAT, IQ, OQ, PQ protocols and reports.
• Perform risk assessments, system impact assessments, and component classifications in accordance with ASTM E2500 and USP <1058>.
• Coordinate with vendors, contractors, and internal stakeholders during commissioning and qualification activities.
• Conduct and document sampling, testing, and verification of utility systems (e.g., TOC, conductivity, microbial testing for water systems).
• Support troubleshooting, deviation management, and implementation of corrective and preventive actions (CAPAs).
• Ensure all activities comply with GMP, GDP, safety, and environmental standards.
• Assist in audits, regulatory inspections, and client reviews by providing documentation and technical expertise.
• Contribute to continuous improvement initiatives and knowledge sharing across project teams.