Process Engineer

5 days ago


Singapore NO DEVIATION PTE. LTD. Full time

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 We are seeking a motivated and technically strong Process Engineer to support a new Technology & Scale‐Up Project within a pilot‐scale manufacturing facility. This role will focus on capital project execution, commissioning & qualification, and process engineering support to enable the safe and efficient introduction of new processes into the facility. You will collaborate closely with operations, engineering, quality, and external vendors to ensure that new equipment and processes are designed, installed, qualified, and implemented in accordance with project requirements, internal standards, and regulatory expectations. Key Responsibilities Lead capital projects from initiation to completion, defining scope, developing execution strategies, and delivering within approved timelines and budgets. Lead cleanroom qualification activities, including environmental qualification, airflow visualization, and classification tests, ensuring compliance with regulatory and internal standards. Identify gaps or limitations in new process capabilities and recommend engineering solutions to enhance plant readiness. Develop and justify project scopes, capital requests, and investment proposals. Lead and oversee commissioning activities, prepare commissioning reports, and ensure smooth handover to operations. Develop, review, and execute IQ/OQ/PQ protocols and related validation documentation in line with GMP and QMS requirements. Address and resolve validation deviations promptly, escalating concerns where necessary. Prepare process engineering documentation to support technology


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