Process Development Senior Engineer

NO DEVIATION PTE. LTD.; Singapore; On-site; SGD 120,000 - 160,000; Full time

Benefits offered by this job

Leave policy

Health & wellness coverage

Professional development

Inclusive culture

Career growth opportunities

Job summary

No deviation PTE. LTD. in Singapore seeks a Senior Process Development Engineer to lead NPI and technology transfer, provide senior technical guidance, and drive continuous improvement in biologics manufacturing.

You will apply deep process knowledge to assess performance, manage risks, and support ready-to-run campaigns within a compliant, cross-functional team. The role requires strong writing and communication skills, extensive experience in cGMP environments, and the ability to mentor PD

Qualifications

• Master's or Bachelor's degree in Engineering, Science or related field with directly related experience.
• 4+ years of related experience for Master’s; 6+ years for Bachelor’s in commercial manufacturing.
• Experience in regulated environments (e.g. cGMP) and in biotech/pharma tech transfer.

Responsibilities

• Independently lead NPI and technology transfer workstreams, including knowledge transfer and risk identification.
• Translate characterization and scale-up knowledge into site requirements and PPQ readiness.
• Identify gaps, develop mitigations, and escalate decisions to PD leadership.
• Provide scientific and engineering support for cell culture, harvest, and purification processes.
• Evaluate manufacturing performance and complex process issues using engineering principles.
• Collaborate with Manufacturing, Quality and other functions to resolve process challenges for reliable manufacturing.
• Lead or guide on deviation investigations, including hypothesis development and data assessment.
• Integrate process and historical data to reach scientifically justified conclusions and recommendations.
• Coach engineers in problem solving and clear technical communication.

Skills

Process development

NPI

Technology transfer

cGMP

Biologics

Education

Master's degree

Bachelor's degree

Tools

Single-use systems

Documentation tools

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

The Senior Process Development Engineer provides experienced scientific and process engineering support for new product introduction (NPI), technology transfer and commercial biologics manufacturing at a Singapore manufacturing site. The role independently executes assigned NPI and technology transfer workstreams, while giving senior technical guidance to the commercial Process Development team on complex investigations, process troubleshooting, campaign readiness, cross-network technical alignment and continuous improvement. The successful candidate will apply strong biologics process knowledge, manufacturing experience and scientific judgment to assess process performance, identify technical risks and develop evidence-based recommendations. The position operates within the established governance structure and is not the formal Technology Transfer Lead, but provides technical leadership for assigned workstreams and escalates key decisions through the Technology Transfer Lead and Process Development leadership.

Key Responsibilities

• Independently lead assigned NPI and technology transfer technical workstreams, including process knowledge transfer, facility and process fit assessment, technical documentation and risk identification
• Translate process characterization, scale-up and manufacturing knowledge into site requirements, and support readiness for engineering runs and PPQ
• Identify technical gaps and risks, develop recommendations and mitigation options, and escalate key decisions through the Technology Transfer Lead and PD leadership
• Provide scientific and engineering support to the commercial PD team for cell culture, harvest and/or purification processes
• Evaluate manufacturing performance and complex process issues using process knowledge, historical experience and engineering principles
• Partner with Manufacturing, Quality and other technical functions to resolve process challenges and support reliable commercial manufacturing
• Lead or provide senior guidance on complex deviation investigations, including hypothesis development, data assessment, root cause evaluation and technical impact assessment
• Integrate process, equipment, manufacturing and historical data to reach scientifically justified conclusions and risk-based recommendations
• Coach PD engineers in structured problem solving, investigation strategy and clear technical communication to Manufacturing, Quality and leadership

Required Qualifications

• Master's degree with 4 years of directly related experience, OR a Bachelor's or advanced degree in Engineering, Science or a related technological field with 6+ years of directly related experience
• 6+ years of relevant experience in a commercial manufacturing environment within the biotechnology or pharmaceutical industries
• At least 4 years of experience in regulated environments (e.g. cGMP)
• Preferred: in-depth cell culture and/or purification process knowledge, including single-use and harvest technologies
• Preferred: understanding of process characterization and scale-up to resolve technical issues during transfer and large-scale manufacturing
• Preferred: experience with floor support, unit operation troubleshooting, and documenting investigations to support cGMP production
• Preferred: experience in technology transfer of new processes and technologies to a commercial site
• Preferred: strong technical writing, verbal communication and presentation skills
• Preferred: strong problem-solving skills grounded in scientific and engineering theory, with the ability to develop hypotheses and determine when additional resources are needed
• Preferred: familiarity with documentation in a highly regulated environment, and the ability to lead small teams and projects

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.