CQ Manager - Drug Substance

No deviation; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A pharmaceutical consultancy in Singapore is seeking a highly skilled CQ Manager to lead the commissioning of Drug Substance manufacturing. Candidates should have over 10 years of CQV experience in biologics, with a strong understanding of GMP standards and bioprocess equipment. This role involves ensuring regulatory compliance and operational excellence in producing life-saving biologics. A competitive leave policy and professional development opportunities are offered.

Benefits

Generous Leave Policy

Comprehensive Health & Wellness Coverage

Professional Development Opportunities

Inclusive Culture

Qualifications

• 10+ years of CQV experience in biologics/Drug Substance environments.
• Strong understanding of bioprocess equipment and GMP validation lifecycle.
• Experience with automation integration is an advantage.

Responsibilities

• Lead CQV activities for bioreactors and associated utilities.
• Prepare and execute commissioning plans and validation documentation.
• Ensure systems meet GMP and regulatory requirements.
• Troubleshoot issues during equipment startup.
• Collaborate with cross-functional teams.
• Support regulatory inspection readiness.

Skills

CQV experience

Bioprocess equipment knowledge

Understanding of GMP validation

Education

Bachelor's degree in Engineering or Biotechnology

Tools

DeltaV

Job description

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.