- Singapore
全职 AUTOMATION SYSTEMS ENGINEER 工作, 薪水 up to SGD 8,500, EnSoft Consulting 公司招聘中 - Ricebowl
分享
保存
工作地点
职位描述
岗位职责
Job Summary
The Engineer is responsible for planning, executing, and documenting commissioning, qualification, and validation activities for process equipment, automation systems, and associated computerized systems within a regulated GMP environment. The role involves supporting system lifecycle activities, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to achieve successful project delivery and operational readiness.
Key Responsibilities
Execute commissioning and qualification activities for process equipment and associated systems.
Develop, review, and execute qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Perform DeltaV functional testing and support system integration and validation activities.
Verify equipment and system operation against User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and applicable GMP requirements.
Coordinate with Engineering, Automation, Validation, Quality Assurance, and Operations teams to identify and resolve technical issues during project execution.
Review, prepare, and approve commissioning, qualification, and validation documentation in accordance with site procedures and regulatory expectations.
Support system startup, troubleshooting, commissioning readiness reviews, and handover to operations.
Ensure all validation and qualification activities are conducted in compliance with company procedures, quality standards, and applicable regulatory guidelines.
Participate in risk assessments, deviation investigations, change controls, and CAPA activities related to validated systems.
Maintain accurate and complete validation records to support regulatory inspections and audits.
Required Qualifications
Bachelor's Degree in Engineering, Information Technology, Electronics, or a related technical discipline.
4+ years of experience in Computer System Validation (CSV), Commissioning & Qualification, or Validation within pharmaceutical, biotechnology, or life sciences industries.
Hands-on experience with DeltaV DCS systems and associated automation platforms.
Strong knowledge of GMP, GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and data integrity requirements.
Experience in developing and executing IQ, OQ, PQ, FAT, SAT, and validation protocols.
Familiarity with process equipment, utility systems, and manufacturing automation systems.
Excellent technical writing, documentation, and communication skills.
Preferred Qualifications
Experience in greenfield or brownfield pharmaceutical projects.
Knowledge of MES, SCADA, PLC, Historian, and integrated automation systems.
Exposure to qualification of computerized systems in sterile, biologics, or pharmaceutical manufacturing facilities.
Ability to manage multiple priorities and work effectively in cross-functional project teams.
Key Competencies
Computer System Validation (CSV)
Commissioning & Qualification
DeltaV Functional Testing
Technical Documentation
Problem Solving & Troubleshooting
Cross-Functional Collaboration
ENSOFT CONSULTING PTE. LTD.
The Engineer is responsible for planning, executing, and documenting commissioning, qualification, and validation activities for process equipment, automation systems, and associated computerized systems within a regulated GMP environment. The role involves supporting system lifecycle activities, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to achieve successful project delivery and operational readiness.
Key Responsibilities
Execute commissioning and qualification activities for process equipment and associated systems.
Develop, review, and execute qualification protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Perform DeltaV functional testing and support system integration and validation activities.
Verify equipment and system operation against User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and applicable GMP requirements.
Coordinate with Engineering, Automation, Validation, Quality Assurance, and Operations teams to identify and resolve technical issues during project execution.
Review, prepare, and approve commissioning, qualification, and validation documentation in accordance with site procedures and regulatory expectations.
Support system startup, troubleshooting, commissioning readiness reviews, and handover to operations.
Ensure all validation and qualification activities are conducted in compliance with company procedures, quality standards, and applicable regulatory guidelines.
Participate in risk assessments, deviation investigations, change controls, and CAPA activities related to validated systems.
Maintain accurate and complete validation records to support regulatory inspections and audits.
Required Qualifications
Bachelor's Degree in Engineering, Information Technology, Electronics, or a related technical discipline.
4+ years of experience in Computer System Validation (CSV), Commissioning & Qualification, or Validation within pharmaceutical, biotechnology, or life sciences industries.
Hands-on experience with DeltaV DCS systems and associated automation platforms.
Strong knowledge of GMP, GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and data integrity requirements.
Experience in developing and executing IQ, OQ, PQ, FAT, SAT, and validation protocols.
Familiarity with process equipment, utility systems, and manufacturing automation systems.
Excellent technical writing, documentation, and communication skills.
Preferred Qualifications
Experience in greenfield or brownfield pharmaceutical projects.
Knowledge of MES, SCADA, PLC, Historian, and integrated automation systems.
Exposure to qualification of computerized systems in sterile, biologics, or pharmaceutical manufacturing facilities.
Ability to manage multiple priorities and work effectively in cross-functional project teams.
Key Competencies
Computer System Validation (CSV)
Commissioning & Qualification
DeltaV Functional Testing
Technical Documentation
Problem Solving & Troubleshooting
Cross-Functional Collaboration
ENSOFT CONSULTING PTE. LTD.
重要安全守则
申请工作时，切勿提供您的银行或信用卡详细资料。不要转账或完成无关的在线调查问卷。如果您发现可疑内容，请举报此招聘广告。
了解更多