Process Development Senior Engineer

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.

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.