CQV Engineer

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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.

Key Responsibilities

• 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.
• 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.

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.

Why join us?

• Generous Leave Policy including 3 days to care for aging family members, reflecting our commitment to family wellbeing.
• Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
• Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
• Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
• Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How To Apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you\'re passionate about making an impact, we want you on our team

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Engineering and Information Technology
• Industries
• Pharmaceutical Manufacturing

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