CQ Manager - Drug Substance

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 highly skilled CQ Manager Drug Substance to lead the commissioning and qualification of our advanced Drug Substance manufacturing facility. In this role, you will play a pivotal part in ensuring that upstream and downstream bioprocess equipment and systems meet the highest quality and regulatory standards. You will coordinate cross-functional teams, drive compliance with GMP and regulatory requirements, and oversee the successful startup of bioreactors, chromatography skids, filtration systems, and associated utilities. This position offers the opportunity to contribute directly to the production of life-saving biologics and ensure operational excellence from facility readiness to regulatory inspection readiness.

Key Responsibilities

• Lead CQV activities for bioreactors, seed trains, chromatography skids, filtration systems, buffer prep, media prep, and associated utilities.
• Prepare and execute commissioning plans, IQ/OQ/PQ protocols, FAT/SAT activities, and validation documentation.
• Ensure systems meet GMP, data integrity, and regulatory requirements (FDA/EU/PICS).
• Troubleshoot and resolve issues during equipment startup.
• Collaborate with Process Engineering, Automation, Manufacturing, QA, and vendors.
• Support regulatory inspection readiness and maintain audit-ready documentation.
• Lead risk assessments, deviation management, and change control for Drug Substance systems.

Required Qualifications

• Bachelors degree in Engineering, Biotechnology, or related field.
• 10+ years CQV experience in biologics/Drug Substance environments (upstream/downstream).
• Strong understanding of bioprocess equipment and GMP validation lifecycle.
• Experience with DeltaV/automation integration is an advantage.

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.