CSV DoQ

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 role is responsible for supporting the implementation, qualification, and commissioning of manufacturing execution and automation systems for packaging operations. This includes leading qualification activities for an Electronic Master Batch Record (eMBR) system and commissioning activities for a SCADA system, ensuring compliance with GxP and GAMP principles. The position will manage end-to-end testing, interface verification, and documentation development to support the transition from paper-based batch records to integrated digital manufacturing systems.

Key Responsibilities

• Lead qualification activities for an Electronic MBR (eMBR) system supporting packaging operations
• Develop and execute qualification deliverables in alignment with GAMP methodology
• Manage end-to-end testing of system interfaces, including MES–SCADA integration
• Draft and review qualification documentation including Qualification Plan, URS, RA, IQ, OQ, PQ, and Qualification Report
• Develop design documentation for configured manufacturing processes within the eMBR system
• Coordinate and manage commissioning activities for a SCADA system supporting packaging operations
• Draft and execute commissioning deliverables including Commissioning Plan, URS, RA, Protocols, and Report
• Ensure effective integration between SCADA and MES systems
• Collaborate with cross-functional teams including Packaging, Automation, IT, and Quality
• Ensure compliance with applicable regulatory, data integrity, and validation requirements

Required Qualifications

• Prior experience qualifying Manufacturing Execution Systems (MES), preferably Electronic MBR solutions
• Hands-on experience with system qualification following GAMP guidelines
• Experience with end-to-end testing of system interfaces (e.g., MES–SCADA)
• Familiarity with packaging operations and automated manufacturing environments
• Experience drafting and executing qualification and commissioning documentation
• Knowledge of SCADA systems; experience with Ignition or similar platforms preferred
• Strong understanding of GxP, data integrity, and validation best practices
• Ability to manage validation and commissioning activities independently

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.