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 EMS CQV Engineer will support the commissioning, qualification, and validation (CQV) of the Environmental Monitoring System (EMS) within a regulated pharmaceutical or biotechnology project environment. This role focuses on ensuring that EMS systems are installed, tested, and documented in compliance with GMP and site quality standards. The engineer will work closely with cross-functional teams, including automation, vendors, and facility engineering, to ensure timely project delivery while maintaining high standards of compliance and documentation integrity.
Key Responsibilities
- Support commissioning, qualification, and validation (CQV) activities for the EMS system
- Prepare and execute CQV documentation, including FAT/SAT, IQ, and OQ protocols and reports
- Ensure all documentation complies with GMP and site quality requirements
- Act as the CQV point of contact for the EMS package during the project phase
- Coordinate with system vendors, automation teams, and facility engineering teams
- Track, manage, and resolve CQV punch list items and deviations
- Support project timelines by ensuring CQV activities are completed as scheduled
- Participate in project meetings and technical discussions with cross-functional stakeholders
- Provide regular progress updates and proactively highlight risks or delays
- Ensure EMS qualification aligns with regulatory expectations and internal procedures
- Support change control processes, deviations, and documentation reviews as required
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or a related discipline
- Proven experience in CQV within the pharmaceutical or biotechnology industry
- Hands-on experience with EMS (Environmental Monitoring Systems) qualification preferred
- Strong knowledge of GMP and regulatory requirements (e.g., FDA, EMA)
- Experience in preparing and executing validation documentation (IQ/OQ, FAT/SAT)
- Familiarity with change control, deviation management, and documentation practices
- Ability to work in a cross-functional, project-based environment
- Strong communication and stakeholder coordination skills
- Detail-oriented with strong organizational and problem-solving abilities
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.
