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CQV Engineer
2 weeks ago
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 (Filling & Packaging Systems) is responsible for the commissioning, qualification, and validation of sterile filling lines, inspection systems, and secondary packaging equipment in compliance with cGMP and regulatory requirements. This role ensures robust qualification and smooth technology transfer for manufacturing operations in pharmaceutical and biotech facilities.
Key Responsibilities
- Plan, develop, and execute CQV lifecycle documentation (URS, DQ, FAT, SAT, IQ, OQ, PQ) for filling and packaging systems
- Lead the qualification of aseptic filling lines, isolators, RABS, cappers, lyophilizers, automated visual inspection, labeling, cartoning, and secondary packaging equipment.
- Conduct system impact assessments, risk assessments, and equipment classifications in line with ASTM E2500 and USP .
- Oversee equipment installation and commissioning, ensuring compliance with design specifications and user requirements.
- Support process simulations/media fills, critical utility connections, and integration with MES/automation systems.
- Coordinate with vendors, contractors, and internal stakeholders during FAT, SAT, and qualification execution.
- Manage and document deviations, non-conformances, and CAPAs arising during qualification.
- Ensure all testing, reports, and documentation adhere to GMP, GDP, Annex 1, Annex 15, and FDA 21 CFR Part 11 requirements.
- Assist with preparation for audits and inspections by providing technical documentation and subject matter expertise.
- Contribute to continuous improvement initiatives and support knowledge transfer to operations.
Required Qualifications
- Bachelors Degree in Engineering, Life Sciences, or related field
- 10 years experience in CQV of sterile filling, inspection, and packaging systems in the pharmaceutical/biotech industry.
- Strong understanding of GMP, Annex 1 (sterile manufacturing), ISPE Baseline Guides, ASTM E2500, and relevant regulatory guidelines.
- Hands-on experience with equipment such as filling machines, isolators/RABS, lyophilizers, AVIs, cappers, and packaging lines.
- Familiarity with automation/CSV aspects (PLC, SCADA, MES) is an advantage.
- Strong technical writing, documentation, and communication skills.
- Ability to work independently and collaborate with cross-functional teams in a fast-paced project environment.
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.
