6 months Project Engineer (Pharma MNC, Up to $5000) #HCG

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:

[email protected]

Tricia Celestine Goh (R1981653)

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