Associate Engineer I
1 week ago
Associate Engineer I (Quality Equipment Technical Support)Join Amgen as an Associate Engineer I (Quality Equipment Technical Support). Amgen is one of the world's leading independent biotechnology companies. For over four decades, Amgen has pioneered biotechnology breakthroughs, bringing state‐of‐the‐art medicines from laboratory to patients. Amgen invested in cutting‐edge manufacturing capability and support services to deliver these therapies worldwide. The Asia Pacific region is growing rapidly, and we are hiring an Associate Engineer in Amgen Singapore Manufacturing. What You Will Do The Associate Engineer reports to the Manager of Quality Equipment Technical Support. This role collaborates with Quality Control (QC) Laboratory, Quality Assurance (QA), the maintenance team and external service providers to perform equipment maintenance and validation activities. The Engineer is the system owner for assigned equipment or systems, performing troubleshooting, preventive‐maintenance oversight and continuous improvement, while contributing to lifecycle management and validation activities. Main Responsibilities Key contributor for assigned equipment performance and operation to ensure safety, compliance and sustained operation. Support the asset life‐cycle management of all quality equipment to maintain compliance with safety/quality regulations, including tracking preventive maintenance and spare‐parts records. Provide daily operational support to ensure continuous equipment availability; coordinate maintenance activities and track issue resolution. Perform and coordinate troubleshooting, repair, and preventive maintenance for analytical instruments and controlled‐temperature chambers, including daily monitoring and coordination with external vendors. Maintain accurate documentation of engineering activities in accordance with current Good Manufacturing Practices (cGMP) and other applicable regulations, ensuring data integrity and audit readiness. Liaise and coordinate with maintenance service providers and users to support the full asset lifecycle, including data management, preventive maintenance, and spare‐parts tracking. Accountable for minor equipment performance deviations and the investigation of major deviations and safety incidents. Support the process of identifying and executing effective corrective and preventive actions and improvements to mitigate future recurrence. Communicate and collaborate with cross‐functional stakeholders to address operational challenges and concerns, ensuring minimal interruptions to operations. Support internal and external audits by preparing documentation, participating in inspection readiness walkdowns, and supporting reviews. Provide support for equipment change controls, commissioning, qualification, system validation, and periodic review activities, contributing technical input in engineering project tasks. Continuous Improvements, Innovation and Operational Sustainability Identify opportunities for continuous improvement to enhance efficiencies and differentiate through advanced technologies and best industry practices. Benchmark equipment performance (e.g., reliability, productivity) and contribute input to improvement activities identified. Periodically review and improve equipment safety, maintenance strategy, spare parts, and other continuous improvement opportunities to enhance reliability. Qualifications Bachelor's degree and 2 years of directly related experience in a pharmaceutical manufacturing site OR Associate's degree and 4 years of directly related experience in a pharmaceutical manufacturing site OR High School Diploma / GED and 6 years of directly related experience in a pharmaceutical manufacturing site. Familiar with documentation in a highly regulated environment. Ability to work independently and collaboratively. Strong understanding of customer voice and quality requirements; a must. Strong team player, effective across teams. Good planning and tracking skills; capable of managing multiple programs with respect to priorities. Highly organized, effectively managing timelines, deliverables, and resources. Strong interpersonal and verbal/written communication skills, distilling complex information into clear messages. Ability to prioritize and multitask in a fast‐paced, rapidly changing environment. Demonstrated critical, creative thinking and problem‐solving skills. Strong customer‐oriented personality. Ability to negotiate and influence peers; knowledge of QC Laboratory and QA Analytical systems and CTC is an advantage. What You Can Expect Of Us Vast opportunities to learn, move up, and cross‐functional experience across our global organization. Diverse and inclusive community that empowers teammates to bring ideas and act. Generous Total Rewards Plan including health, finance and wealth benefits, work/life balance, and career development. Your selection for this role will be subject to fulfilling the medical requirements of this job scope. Any medical checks required will be paid for by Amgen. Apply now for a career that defies imagination. careers.amgen.com Equal Opportunity Statement Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will provide reasonable accommodations for individuals with disabilities to participate in the job application or interview process. Seniority Level Not Applicable Employment Type Full‐time Job Function Biotechnology Research and Pharmaceutical Manufacturing Referrals Referrals increase your chances of interviewing at Amgen by 2×. #J-18808-Ljbffr
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