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
We are seeking a Qualification Engineer lead commissioning, qualification, and validation (CQV) activities for HVAC systems, cleanrooms, and critical utilities within a GMP-regulated pharmaceutical environment.
The role will focus on end-to-end qualification lifecycle execution, ensuring compliance with EU GMP Annex 15, ASTM E2500, and industry best practices.
Key Responsibilities
- Commissioning & Qualification Execution
- Support CQV lifecycle activities for HVAC, cleanrooms, and utilities systems (e.g., PW, WFI, Clean Steam, compressed air).
- Execute IQ, OQ, and PQ protocols for facilities and utilities systems.
- Participate in commissioning activities including system walkdowns and punch listing.
- Perform functional testing and verification of system performance. - Documentation & Protocol Development
- Develop and/or execute qualification documents: URS (review), SIA (System Impact Assessment), Risk Assessments / Criticality Assessments
- DQ, IQ, OQ, PQ protocols and reports
- Ensure traceability through RTM (Requirements Traceability Matrix) - HVAC & Cleanroom Qualification
Perform or support:
- Airflow visualization (smoke studies)
- HEPA filter integrity testing (PAO/DOP)
- Air velocity and air change rate verification
- Temperature and humidity mapping
- Room pressure cascade verification - Utilities Qualification
- Support qualification of:
- Water systems (PW/WFI loops)
- Clean steam systems
- Compressed gases (CDA, nitrogen, oxygen)
- Execute sampling and testing activities in collaboration with QA/QC teams - Stakeholder Coordination
Work closely with:
- Engineering / Facilities teams
- Vendors and system integrators
- QA/Validation teams
- Support FAT/SAT activities where required - GMP Compliance & Quality
- Ensure all activities comply with:
- cGMP requirements
- Data integrity (ALCOA+) principles
- Support deviations, CAPA, and change control activities
Required Qualifications
- Education
Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical or related discipline) - Experience
5 years of relevant CQV/Validation experience in pharmaceutical or biotech industry - Hands-on experience in
- HVAC / cleanroom qualification
- Utilities systems qualification
- Technical Skills - Familiar with
- EU GMP Annex 15
- ASTM E2500
- ISPE Baseline Guides (Volume 5 - Commissioning & Qualification) - Strong understanding of
- HVAC systems and cleanroom classifications (Grade A-D)
- Utilities systems design and operation - Soft Skills
- Strong documentation and technical writing skills
- Good stakeholder management and communication skills
- Ability to work independently and in cross-functional teams
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.
