- Outram Central Region (Singapore) Singapore
全职 QC-QA Engineer (Biotech) 工作, 薪水 up to SGD 5,500, PERSOL Central Region (Singapore) 公司招聘中 - Ricebowl
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职位描述
岗位职责
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
By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOL Singapore Pte Ltd ("PERSOL") and its local and overseas subsidiaries and affiliates to collect, use and disclose your personal data to prospective employers/companies based in any country for purposes of evaluating suitability for employment, conducting reference checks, administering employment related services, complying with Government’s health advisories and such other purposes stated in our Privacy Policy.
We may use artificial intelligence ("AI") and machine learning technologies to support our recruitment and placement services, including screening resumes, assessing qualifications and experience, and identifying skills and job matches. Where permitted by applicable law, we may also use such personal data to develop, train, test, improve and/or fine-tune AI and machine learning technologies that support our recruitment and business operations.
For more information on how we collect, use, disclose and protect your personal data, please refer to our Privacy Policy: ************* you wish to withdraw your consent, including consent relating to the use of your personal data for AI-enabled recruitment activities and AI development activities, please email us at
*************
.
PERSOL Singapore Pte Ltd • RCB No. 200007268E • EA License No. 01C4394 • EA Registration No. R1877971 (Derrick Tiew Yong Han)
PERSOL is Asia-Pacific’s leading Staffing and HR solutions partner, operating across 13 markets with deep local insight and regional scale. With more than 80 offices and decades of experience, we deliver integrated workforce solutions that are tailored, tech-enabled, and designed for the dynamic world of work.
We combine human expertise with smart technology to help organisations solve workforce challenges, unlock potential, and stay ahead of change. From recruitment and talent management to workforce strategy and advisory, our collaborative approach puts your goals at the centre.
In 2025, we came together under the PERSOL name — reflecting our bold vision for the future of work and our Group’s Vision: Work and Smile.
Whether you’re building teams, growing careers, or transforming how work gets done, we’re here.
By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOL Singapore Pte Ltd and its local and overseas subsidiaries and affiliates to collect, use and disclose your personal data to prospective employers/companies based in any country for purposes of evaluating suitability for employment, conducting reference checks, administering employment related services, complying with Government’s health advisories and such other purposes stated in our Privacy Policy.
Our full Privacy Policy is available at ************* If you wish to withdraw your consent, please drop us an email at "*************" to let us know. Please feel free to contact us if you have any queries.
For more information, please visit *************
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
By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOL Singapore Pte Ltd ("PERSOL") and its local and overseas subsidiaries and affiliates to collect, use and disclose your personal data to prospective employers/companies based in any country for purposes of evaluating suitability for employment, conducting reference checks, administering employment related services, complying with Government’s health advisories and such other purposes stated in our Privacy Policy.
We may use artificial intelligence ("AI") and machine learning technologies to support our recruitment and placement services, including screening resumes, assessing qualifications and experience, and identifying skills and job matches. Where permitted by applicable law, we may also use such personal data to develop, train, test, improve and/or fine-tune AI and machine learning technologies that support our recruitment and business operations.
For more information on how we collect, use, disclose and protect your personal data, please refer to our Privacy Policy: ************* you wish to withdraw your consent, including consent relating to the use of your personal data for AI-enabled recruitment activities and AI development activities, please email us at
*************
.
PERSOL Singapore Pte Ltd • RCB No. 200007268E • EA License No. 01C4394 • EA Registration No. R1877971 (Derrick Tiew Yong Han)
PERSOL is Asia-Pacific’s leading Staffing and HR solutions partner, operating across 13 markets with deep local insight and regional scale. With more than 80 offices and decades of experience, we deliver integrated workforce solutions that are tailored, tech-enabled, and designed for the dynamic world of work.
We combine human expertise with smart technology to help organisations solve workforce challenges, unlock potential, and stay ahead of change. From recruitment and talent management to workforce strategy and advisory, our collaborative approach puts your goals at the centre.
In 2025, we came together under the PERSOL name — reflecting our bold vision for the future of work and our Group’s Vision: Work and Smile.
Whether you’re building teams, growing careers, or transforming how work gets done, we’re here.
By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOL Singapore Pte Ltd and its local and overseas subsidiaries and affiliates to collect, use and disclose your personal data to prospective employers/companies based in any country for purposes of evaluating suitability for employment, conducting reference checks, administering employment related services, complying with Government’s health advisories and such other purposes stated in our Privacy Policy.
Our full Privacy Policy is available at ************* If you wish to withdraw your consent, please drop us an email at "*************" to let us know. Please feel free to contact us if you have any queries.
For more information, please visit *************
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