QC/QA Engineer (Biotech)

About the company

The Engineer will report to Manager, Quality Equipment Technical Support. This role is part of a team which collaborates with Quality Control (QC) Laboratory and Quality Assurance (QA), maintenance team and external service providers to perform equipment maintenance and validation activities.

Your tasks

Daily Operations

• Subject matter expert for assigned equipment or systems performance to ensure safety, compliance and sustained operation.
• Independently perform and coordinate troubleshooting, repair, and preventive maintenance for analytical instruments and controlled temperature chambers, including daily equipment monitoring and coordination with external vendors.
• Maintain accurate documentation of engineering activities in accordance with current Good Manufacturing Practices (cGMP) and other applicable regulations.
• Effectively communicate and collaborate with cross function stakeholders to address operational challenges and concerns to ensure sustained operation and minimal interruptions to operations activities.
• Present equipment qualification, analytical system validation package, equipment related investigations and quality management system records in all site regulatory inspections.
• Ensure operation continuity through asset lifecycle management planning, assess and identify impact to safety, compliance, operational schedule and cost.
• Perform assessment for equipment during new product introduction, change controls and other qualifications activities to ensure equipment are in its validated state.
• Support and occasionally lead deviation and safety incidents root cause analysis relating to equipment performance and corrective/preventive actions (CAPA) implementation.
• Liaise and coordinate with maintenance service providers and users as needed to support the full asset lifecycle, such as data management, preventive maintenance, and spare parts tracking.
• Participate in engineering project tasks to ensure compliance with safety, quality, and operational standards.
• Perform periodic review and maintain process equipment in validated state.

Continuous improvements, Innovation and operational sustainability

• Actively seek opportunities for continuous improvement to improve efficiencies and differentiation through flexible use of advance technologies and best industry practices.
• Periodically review and/or improve equipment safety, maintenance strategy, spare parts, and other continuous improvement opportunities to enhance reliability.
• Work independently with project managers to complete engineering projects of various scales within schedule, budget, and quality constraints.

Organization Leadership

• Work in teams by educating customers on lesson learns, collaborate with customers managers to identify knowledge or trainings gaps.
• Deliver strong result in the right way by consciously being a role model that ensure results are deliver without compromising on core AMGEN values.

Requirements

Preferred Qualifications

• Bachelor's degree in engineering or any relevant field and 4 years of directly related experience in a pharmaceutical manufacturing site
• Strong understanding of equipment maintenance, calibration, and validation principles.
• Familiar with documentation in a highly regulated environment

Other

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PERSOL Singapore Pte Ltd • RCB No. 200007268E • EA License No. 01C4394 • EA Registration No. R1877971 (Derrick Tiew Yong Han)