Project Cleanroom CQV Engineer

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 Project Engineer – Cleanroom CQV is responsible for planning, coordinating, and executing commissioning, qualification, and validation (CQV) activities for GMP cleanrooms within a project environment. This role ensures that cleanroom systems are designed, constructed, commissioned, and qualified in compliance with regulatory and GMP requirements, and are successfully handed over to operations in a state of operational readiness.

Key Responsibilities

• Execute IQ / OQ / PQ for cleanrooms and controlled environments, including architectural elements such as walls, ceilings, doors, and finishes
• Coordinate and support cleanroom readiness activities, including walkdowns, punch-list management, and closure
• Support cleanroom startup and operational readiness activities
• Support project schedules related to cleanroom CQV milestones
• Participate in design reviews, risk assessments, and constructability reviews
• Coordinate with contractors and vendors during installation completion, commissioning, and qualification activities
• Support FAT / SAT activities where applicable
• Coordinate or support cleanroom performance testing, including airflow visualization (smoke studies), air velocity and airflow uniformity, particle count testing (ISO 14644), room recovery, and pressure differential testing
• Ensure testing results are documented, reviewed, and approved in accordance with GMP requirements
• Prepare, execute, and review cleanroom risk assessments, IQ/OQ/PQ protocols and reports, change controls, and deviations
• Ensure CQV documentation is complete, traceable, and inspection-ready
• Support internal and regulatory inspections related to cleanroom CQV scope
• Work closely with project management, engineering, QA, validation, operations teams, and external vendors
• Support the handover of qualified cleanrooms to manufacturing or QC operations

Required Qualifications

• Diploma or Bachelors degree in Engineering (Mechanical, Chemical, Building Services), Facilities or Environmental Engineering, or a related discipline
• 3–10 years of experience in cleanroom CQV or validation roles within pharmaceutical or biotechnology projects
• Hands-on experience executing cleanroom IQ/OQ/PQ activities
• Experience coordinating environmental performance testing
• Project-based experience on greenfield and/or brownfield projects is strongly preferred

Why join us?

• Generous Leave Policy.
• 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.