No deviation

QC CQV Engineer

No deviation  •  Singapore, SG (Onsite)  •  3 months ago
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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.

The QC CQV Engineer is responsible for the commissioning, qualification, and validation of QC laboratory equipment, with a strong focus on temperature‑controlled units such as refrigerators and freezers. This role will support change control activities, develop qualification protocols, execute testing, and ensure compliance with GMP and data integrity requirements.

Key Responsibilities

Temperature Mapping & Equipment Qualification

  • Perform temperature mapping of refrigerators, freezers, and other temperature‑controlled equipment according to GMP requirements.
  • Analyze mapping data and ensure equipment meets acceptance criteria for uniformity and stability.
  • Support qualification activities including IQ/OQ/PQ for QC laboratory instruments.
  • Document all qualification activities in compliance with internal procedures and regulatory standards.

Protocol Development & Execution

  • Draft validation documents such as URS, Risk Assessments, IQ/OQ/PQ protocols, and summary reports.
  • Execute qualification protocols in the QC laboratory environment.
  • Ensure all deviations are documented, investigated, and resolved appropriately.

Change Control & Compliance

  • Initiate and manage Change Controls related to equipment qualification, upgrades, repairs, or replacements.
  • Ensure all activities align with GMP, ALCOA+, and regulatory expectations.
  • Support internal and external audits by presenting qualification and validation documentation.

Cross-Functional Collaboration

  • Work closely with QC, QA, Engineering, and vendors to coordinate qualification and maintenance activities.
  • Provide technical support to the QC team on equipment performance and compliance.
  • Participate in continuous improvement initiatives for laboratory equipment lifecycle management.

Required Qualifications

  • Degree or Diploma in Engineering, Life Sciences, Biotechnology, or related field.
  • Experience in CQV, equipment qualification, and temperature mapping in a GMP environment.
  • Strong understanding of qualification principles, validation lifecycle, and regulatory requirements.
  • Good documentation, analytical, and problem‑solving skills.
  • Strong attention to detail and compliance mindset
  • Good communication and technical writing skills
  • Ability to work independently and in cross‑functional teams
  • Practical understanding of laboratory operations

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.

No deviation

About No deviation

Founded in 2007, No deviation is a trusted partner to pharmaceutical and biotech companies seeking smarter ways to deliver compliance. From engineering consultancy to CQV execution, regulatory compliance, and digital enablement, we support our clients across the entire project lifecycle in Asia, Europe.

We specialise in:

CQV (Commissioning, Qualification & Validation)

Lean, risk-based approaches aligned with GAMP 5, Annex 15, and ASTM E2500.

Quality, Compliance & Regulatory

Audit readiness, QMS remediation, documentation, and training.

Project Management & Technical Support

From operational readiness to vendor coordination.

Digital Enablement

Implementation of paperless validation (e.g. Kneat Gx), data integrity, and process digitalisation.

Specialised Training & Talent Support

Upskilling programs and resource placement to accelerate project success.

Our approach is rooted in patient safety, process understanding, regulatory compliance, and a constant drive for operational excellence in terms of safety, quality, delivery, and cost.

If you’re troubleshooting a deviation, planning a major CQV deployment, or scaling digital validation tools, we work side-by-side with your teams to deliver meaningful outcomes. Our methodology draws from ICHQ9 risk principles, with a hands-on framework: Understand - Observe - Define - Implement.

Want to learn more about paperless CQV, digital QMS, or project-ready resources? We’re happy to talk. Visit nodeviation.com to explore how we can support you.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Singapore, SG
Year Founded
2007
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