Senior CQV Engineer (Chemical)

NOVEXX PTE. LTD.; Singapore; On-site; SGD 80,000 - 100,000; Full time

Job summary

A biotechnology company based in Singapore is seeking an experienced Process Engineer. The ideal candidate will oversee capital projects, enhance processing capabilities, and ensure high-quality standards are met throughout operations. Expertise in commissioning, validation, and a degree in chemical engineering are essential for success in this role. The company promotes continuous improvement in a dynamic environment.

Qualifications

• 7 years or above experience in process engineering, manufacturing, or pilot plant operations.
• Expertise in commissioning, qualification, and validation practices.
• Experience in capital project execution.

Responsibilities

• Oversee capital projects from initiation through completion.
• Assess existing Oligo processing technologies and recommend improvements.
• Lead commissioning activities and prepare reports.

Skills

Process engineering expertise

Commissioning and qualification practices

Capital project execution

Equipment troubleshooting

Education

Degree in chemical engineering or relevant course

Job description

Job scope

• Oversee capital projects from initiation through completion by defining scope, developing execution plans, and ensuring all phases are delivered on schedule and within budget.
• Assess existing Oligo processing technologies, identify performance gaps, and recommend improvements to strengthen plant capabilities.
• Prepare and secure approval for project scopes, capital expenditure requests, and Project Investment Proposals (PIPs).
• Evaluate contractor and supplier design submissions to ensure they meet user needs, Engineering Standards (GES), and QMS requirements.
• Lead commissioning activities, prepare commissioning reports, and ensure seamless handover of projects to operations teams.
• Manage procurement of equipment and instrumentation, confirming suitability for Oligo-related processes.
• Ensure contractor work is executed safely and to high quality standards, following EHS, GMP, and engineering guidelines.
• Serve as a Subject Matter Expert (SME) and collaborate with Automation Engineers to design and implement automation solutions as needed.
• Lead and support commissioning and qualification of new technologies and equipment used for Oligo production.
• Develop, implement, and review qualification and validation protocols (IQ/OQ/PQ), along with all necessary GMP- and QMS-compliant documentation.
• Drive timely resolution of validation deviations and elevate issues when appropriate.
• Ensure new systems are effectively integrated into pilot plant operations, including documentation updates and operator training.
• Provide process engineering expertise to support the introduction and scale-up of Oligo processes in the pilot plant.
• Assist operations teams during production campaigns by troubleshooting process or equipment-related problems.
• Partner with scientists, engineers, and operational staff to ensure plant configuration and equipment capabilities meet evolving process requirements.
• Participate in hazard and risk assessments for new Oligo processes.
• Produce comprehensive process engineering documents to support the transfer of Oligo processes into manufacturing environments.
• Collaborate with cross-functional teams to design processes that are safe, scalable, and efficient for commercial manufacturing.
• Promote continuous improvement by recommending enhancements to equipment, automation, and processes based on campaign insights.

Requirements

• 7 years or above experience in process engineering, manufacturing, or pilot plant operations
• Expertise in commissioning, qualification, and validation (CQV) practices
• Capital project execution and equipment troubleshooting experience
• Degree in chemical engineering or relevant course