About this role
Job Scope• Support and manage engineering changes within the site engineering function by coordinating with Automation, Manufacturing, MS, QS, Validation, and end users to implement process and system improvements. • Lead and manage change control activities for process engineering and recipes, ensuring timely creation, implementation, documentation, and closure in compliance with GMP and company requirements. • Collaborate with SMEs and cross-functional teams to ensure systems, equipment, controls, and operational processes are fit-for-purpose and aligned with business and manufacturing needs. • Support and drive process improvement initiatives, including troubleshooting technical and equipment-related issues, implementing corrective actions, and ensuring successful delivery of project outcomes. • Conduct process safety assessments and hazard identification activities while ensuring equipment operating parameters are aligned with process and product requirements. • Prepare, maintain, and complete technical and compliance documentation to ensure proper traceability, audit readiness, and adherence to regulatory and EHS requirements. • Provide technical support and training to end users on implemented engineering and process changes when required. • Utilise systems such as TrackWise and Kneat for change control management, documentation, and testing activities. • Work closely with cross-functional and multidisciplinary teams to ensure effective communication, stakeholder alignment, and operational support. • Ensure compliance with GMP standards, EHS requirements, company policies, and operational procedures while supporting additional responsibilities assigned by management. Requirements• Degree in Chemical, Bio, Process, Mechanical Engineering, or a related engineering discipline. • Minimum 2 years of process engineering experience within Biologics, Pharmaceutical, or similar manufacturing industries. • Experience in change control systems such as TrackWise and Kneat testing platform is highly preferred. • Knowledge and understanding of GMP-regulated manufacturing environments. • Familiarity with biopharmaceutical manufacturing equipment and facility operations is an added advantage. • Strong problem-solving, troubleshooting, and process improvement capabilities. • Good stakeholder management and cross-functional communication skills. • Ability to work effectively within multidisciplinary teams and manage multiple priorities in a fast-paced environment. • Understanding of process safety, compliance, and EHS requirements within manufacturing operations. • Prior leadership or project coordination experience within cross-functional teams is an added advantage. All qualified applicants, please send in your resume to: triciagoh@recruitexpress.com.sg Tricia Celestine Goh (R1981653) Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599
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