QC/QA Engineer (Biotech)

PERSOL; Singapore; On-site; SGD 70,000 - 90,000; Full time

Job summary

PERSOL is seeking an Equipment Engineer for our Singapore site. You will report to the Manager, Quality Equipment Technical Support, and collaborate with QC Laboratory, QA, maintenance, and external service providers to maintain and validate critical equipment.

Your daily duties include troubleshooting, preventive maintenance for analytical instruments and controlled temperature chambers, validating equipment, and ensuring cGMP compliance with thorough documentation.

Qualifications

• Bachelor’s degree in engineering and 4 years of related pharma manufacturing experience.
• Strong understanding of equipment maintenance, calibration and validation principles.
• Familiar with documentation in a highly regulated environment.

Responsibilities

• Subject matter expert for equipment performance to ensure safety and compliance.
• Perform and coordinate troubleshooting, repair and preventive maintenance for analytical instruments.
• Maintain documentation of engineering activities in line with cGMP and regulations.
• Collaborate with cross-functional teams to address operational challenges and minimize downtime.
• Present qualification and validation packages during site inspections.
• Manage asset lifecycle planning and assess impacts on safety and cost.
• Assess equipment during product introductions and change controls for validated state.
• Support deviation and CAPA investigations related to equipment.
• Coordinate with maintenance providers for data management and spare parts.
• Contribute to engineering projects ensuring safety, quality and standards.
• Periodic review and maintenance of equipment in validated state.
• Actively pursue continuous improvement through advanced technologies.

Skills

Equipment maintenance

Troubleshooting

Documentation

Regulatory compliance

Cross-functional

Education

Bachelor's degree in engineering

Tools

Calibration equipment

Analytical instruments

Job description

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.

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.

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