QC/QA Engineer (Biotech)

PERSOL SINGAPORE PTE. LTD.; Singapore; On-site; SGD 85,000 - 120,000; Full time

Job summary

PERSOL SINGAPORE PTE. LTD. is seeking an Engineer to join the Quality Equipment Technical Support team in Singapore.

The role collaborates with QC Laboratory, QA, maintenance, and external service providers to perform maintenance and validation of analytical equipment and controlled environments. You will provide subject matter expertise, lead troubleshooting and preventive maintenance, ensure cGMP documentation, and participate in equipment qualification and system validation activities,

Qualifications

• Bachelor's degree in engineering or related field required.
• 4 years of directly related experience in a pharmaceutical manufacturing site.
• Strong understanding of equipment maintenance, calibration, and validation principles.

Responsibilities

• Perform preventive maintenance for analytical instruments and controlled temperature chambers.
• Maintain accurate cGMP documentation for engineering activities.
• Coordinate with maintenance vendors and external service providers as needed.

Skills

Equipment maintenance

Calibration and validation

Regulatory documentation

Education

Bachelor's degree in engineering or related field

4 years of directly related experience in a pharmaceutical manufacturing site

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