No deviation

Operations Engineer

No deviation  •  Singapore, SG (Onsite)  •  4 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 Operations Engineer supports project and start-up phase activities for Media and Buffer Preparation systems within a GMP biologics manufacturing environment. This role focuses on ensuring systems are execution-ready by reviewing automation logic, recipes, and MES workflows, while supporting dry runs, simulations, and start-up readiness activities. The Operations Engineer works cross-functionally with operations, automation, engineering, validation, and quality teams to ensure smooth transition from project to routine manufacturing in compliance with GMP requirements.

Key Responsibilities

  • Support project and start-up phase activities for Media and Buffer Preparation systems in a GMP biologics facility
  • Review and verify DeltaV recipes and unit procedures (UP level) to ensure execution readiness
  • Check sequencing, parameters, and execution logic to confirm correct system setup for operations
  • Support MES workflows and electronic batch records aligned with approved process logic
  • Participate in execution dry runs, simulations, and start-up readiness activities
  • Identify and escalate gaps or issues in system setup or execution logic to relevant teams
  • Apply basic IOQ knowledge to support equipment readiness and start-up activities
  • Support preparation and review of start-up and GMP documentation
  • Collaborate closely with operations, automation, engineering, validation, and quality teams

Required Qualifications

  • Bachelors degree in Engineering, Biotechnology, or a related technical discipline
  • Experience in GMP biologics, pharmaceutical, or life sciences manufacturing environments
  • Working knowledge of DeltaV automation systems, particularly recipe and unit procedure execution
  • Familiarity with MES workflows and electronic batch record systems
  • Basic understanding of IOQ and equipment start-up activities
  • Strong attention to detail and ability to identify system and execution gaps
  • Good communication skills and ability to work effectively in cross-functional teams

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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