No deviation

Downstream Process Owner

No deviation  •  Singapore, SG (Onsite)  •  6 days 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.

We are looking for a detail-oriented and results-driven Downstream Engineer to join our dynamic team. In this role, you will be responsible for the development, optimization, and support of downstream processing systems to ensure efficient product recovery, purification, and operational excellence. You will work closely with cross-functional teams to support both day-to-day manufacturing and long-term process improvements, contributing to the successful delivery of high-quality products in a GMP-regulated environment.

Key Responsibilities

  • Design, develop, and optimize downstream processes (e.g., filtration, chromatography, centrifugation) for large-scale production.
  • Apply engineering principles to recommend, design, and implement new equipment or system modifications.
  • Work closely with cross-functional teams including manufacturing, engineering, utility operations, maintenance, quality assurance, and validation to drive operational improvements.
  • Provide technical support to commercial manufacturing operations as needed.
  • Troubleshoot and resolve equipment, automation, or process-related issues in the field.
  • Ensure optimal and cost-effective performance and reliability of process systems.
  • Develop, organize, analyze, and present results for operational issues and engineering projects of moderate scope and complexity.
  • Proactively communicate with supervisors and cross-functional partners, highlighting issues and proposing practical solutions.
  • Act as a technical expert to help introduce advanced technologies and "Next Generation Manufacturing" approaches into the plant.
  • Manage change controls, deviations, CAPAs, and process equipment documentation.
  • Oversee implementation, development, and changes related to process equipment Commissioning, Qualification, and Validation (CQV).
  • Prepare, coordinate, and present complex technical data at cross-functional meetings and management reviews.
  • Provide on-call technical support as required.

Required Qualifications

  • Bachelor's or Master's degree in Chemical Engineering, Bioprocess Engineering, Biotechnology, or a related field
  • Minimum 2+ years of experience in downstream processing, preferably in a GMP-regulated environment
  • Hands-on experience with purification techniques such as chromatography, ultrafiltration/diafiltration, and virus filtration
  • Familiarity with change control systems, validation processes, and deviation management
  • Strong analytical and troubleshooting skills
  • Excellent communication and interpersonal skills
  • Ability to work effectively in cross-functional teams with a collaborative mindset

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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