Total 10 job vacancies by Cutech Quality Solutions Pte. Ltd.

Responsibilities

• Develop and implement Enterprise Risk Management (ERM) frameworks covering Strategic Risk, Operational Risk, Project Risk, Technology Risk, Cybersecurity Risk, Quality Risk, Supply Chain Risk, Health, Safety, Security and Environmental (HSSE) Risk, and Compliance Risk. 
• Establish risk governance policies, procedures, risk registers, risk appetite frameworks, and internal control mechanisms across engineering, inspection, testing, software development, and automation business functions. 
• Conduct enterprise-wide risk assessments and identify potential risks associated with engineering projects, operational processes, technology systems, digital solutions, and business operations. 
• Develop and maintain risk assessment methodologies, risk scoring models, Key Risk Indicators (KRIs), risk dashboards, and management reporting systems. 
• Perform trend analysis, root cause analysis, scenario analysis, and predictive risk assessments to support business decision-making and operational resilience. 
• Monitor project risks related to cost, schedule, quality, safety, resource allocation, and contractual obligations throughout the project lifecycle. 
• Lead technology and cybersecurity risk assessments for IT infrastructure, cloud platforms, software applications, automation systems, and digital transformation initiatives. 
• Develop risk analytics solutions and automate risk monitoring and reporting processes using data analytics, business intelligence, and visualization tools. 
• Manage enterprise risk data, data quality controls, and governance processes to ensure accurate and reliable risk reporting. 
• Support business continuity planning, operational resilience initiatives, and crisis management preparedness programs. 
• Collaborate with engineering, operations, quality assurance, software development, IT, and management teams to strengthen risk controls, governance standards, and compliance practices. 
• Lead risk management system implementation, enhancement, integration, and process improvement initiatives to improve risk visibility and operational efficiency. 
• Support the adoption of digital technologies, AI-enabled analytics, workflow automation, and data-driven risk management practices. 
• Conduct risk awareness training and promote a strong risk management culture across the organization. 

Requirements

• Bachelor's degree in engineering, Information Technology, Computer Science, Data Analytics, Risk Management, Business Management, or a related discipline. 
• Minimum 10 years of relevant experience in Enterprise Risk Management, Operational Risk Management, Project Risk Management, Technology Risk, Quality Management, Compliance, or Governance functions. 
• Strong expertise in risk identification, risk assessment, risk mitigation planning, risk monitoring, risk reporting, and internal control frameworks. 
• Experience in managing risks associated with engineering projects, inspection and testing services, software development, digital transformation initiatives, or automation solutions. 
• Hands-on experience in developing risk dashboards, Key Risk Indicators (KRIs), management reporting, and performance monitoring frameworks. 
• Advanced proficiency in Python, SQL, and data analytics tools for risk analysis, automation, reporting, and process improvement. 
• Experience with statistical analysis, predictive analytics, machine learning applications, and data-driven decision-making methodologies. 
• Strong knowledge of data governance, data quality management, data warehousing, ETL processes, and enterprise data management practices. 
• Proficiency in business intelligence and data visualization tools such as Power BI, Tableau, QlikView, or similar platforms. 
• Experience with enterprise risk management systems, Governance, Risk and Compliance (GRC) platforms, project management systems, or operational management solutions. 
• Familiarity with cloud technologies (AWS, Azure), API integration, workflow automation platforms, and digital business applications. 
• Strong understanding of ISO 31000 Risk Management, ISO 9001 Quality Management Systems, ISO 27001 Information Security Management Systems, ISO 45001 Occupational Health and Safety Management Systems, and relevant regulatory compliance requirements. 
• Excellent analytical, problem-solving, stakeholder management, communication, and leadership skills. 
• Ability to lead cross-functional teams and drive enterprise-wide risk management and governance initiatives.

Job Description:

1. Supervise M&E installation works (electrical, HVAC, plumbing, fireprotection, ELV).
2.   Ensurecompliance with approved drawings, specifications, and Building andConstruction Authority requirements.
3.   Conduct siteinspections, quality checks, and material verification.
4.   Witnesstesting & commissioning (T&C) and SAT.
5.   Coordinatewith all trades and specialist contractors.
6.   Monitorprogress and submit site reports.
7.   Ensuresafety and statutory compliance with SCDF and relevant authorities.
8.   Assist inTOP/CSC documentation and handover.

Requirements:
1.Should have at least three(3) years of relevant experience as a M&E RTO, of which at least two years shall be in the supervision of works similar in nature to works in the Civil Contract.
2.Should have a diploma in the mechanical/electrical discipline with qualification accredited by the Commissioner of Building Control and accredited by JAC of IES/ACES as QSS.

Key Responsibilities:

• Perform DeltaV Batch configuration including recipes, phases, equipment modules (EM), and control modules (CM).
• Lead and execute DeltaV system validation activities, including authoring and executing IQ, OQ, and IOQ protocols.
• Manage system administration and maintain configuration integrity across development, test, and production environments.
• Troubleshoot, validate, and support integration of standalone systems with DeltaV DCS.
• Lead automation commissioning and Site Acceptance Testing (SAT) for facility and equipment upgrades.
• Manage and coordinate CQV (Commissioning, Qualification, and Validation) activities with cross-functional teams.
• Generate and execute validation documentation for DeltaV and Rockwell BAS systems, in compliance with GAMP5, 21 CFR Part 11, and EU Annex 11.
• Liaise with equipment vendors, internal stakeholders, and IT teams to implement upgrades and resolve system issues.
• Provide routine operational support for automation and control systems including during preventive maintenance and shutdown periods.
• Engage in incident resolution, root cause analysis, and implement corrective actions to maintain operational excellence.

Requirements:

• Minimum 5+ years of experience in automation engineering with a strong focus on DeltaV DCS.
• Hands-on experience with validation and compliance for regulated environments (GMP, FDA, EU Annex 11).
• DeltaV DCS (Batch, Safety, Historian, Configuration, Administration)
• Rockwell BAS, SCADA, PLC (Allen-Bradley, Yokogawa, Invensys)
• Validation protocols: IQ, OQ, PQ, IOQ
• GAMP5, 21 CFR Part 11, EU Annex 11, ASTM E2500
• MES, OPC (DA, UA), Fieldbus, HMI systems
• SDLC & Change Control documentation
• Strong project management and stakeholder communication.
• Excellent analytical, troubleshooting, and documentation skills.
• Ability to lead cross-functional teams and train junior engineers.
• Willingness to support 24/7 operations and emergency response as required

Key Responsibilities:

• Perform DeltaV Batch configuration including recipes, phases, equipment modules (EM), and control modules (CM).
• Lead and execute DeltaV system validation activities, including authoring and executing IQ, OQ, and IOQ protocols.
• Manage system administration and maintain configuration integrity across development, test, and production environments.
• Troubleshoot, validate, and support integration of standalone systems with DeltaV DCS.
• Lead automation commissioning and Site Acceptance Testing (SAT) for facility and equipment upgrades.
• Manage and coordinate CQV (Commissioning, Qualification, and Validation) activities with cross-functional teams.
• Generate and execute validation documentation for DeltaV and Rockwell BAS systems, in compliance with GAMP5, 21 CFR Part 11, and EU Annex 11.
• Liaise with equipment vendors, internal stakeholders, and IT teams to implement upgrades and resolve system issues.
• Provide routine operational support for automation and control systems including during preventive maintenance and shutdown periods.
• Engage in incident resolution, root cause analysis, and implement corrective actions to maintain operational excellence.

Requirements:

• Minimum 4 years of experience in automation engineering with a strong focus on DeltaV DCS.
• Hands-on experience with validation and compliance for regulated environments (GMP, FDA, EU Annex 11).
• DeltaV DCS (Batch, Safety, Historian, Configuration, Administration)
• Rockwell BAS, SCADA, PLC (Allen-Bradley, Yokogawa, Invensys)
• Validation protocols: IQ, OQ, PQ, IOQ
• GAMP5, 21 CFR Part 11, EU Annex 11, ASTM E2500
• MES, OPC (DA, UA), Fieldbus, HMI systems
• SDLC & Change Control documentation
• Strong project management and stakeholder communication.
• Excellent analytical, troubleshooting, and documentation skills.
• Ability to lead cross-functional teams and train junior engineers.
• Familiarity with tools like Emerson’s Kneat Gx for paperless validation
• Willingness to support 24/7 operations and emergency response as required

Key Responsibilities:

• Perform DeltaV Batch configuration including recipes, phases, equipment modules (EM), and control modules (CM).
• Lead and execute DeltaV system validation activities, including authoring and executing IQ, OQ, and IOQ protocols.
• Manage system administration and maintain configuration integrity across development, test, and production environments.
• Troubleshoot, validate, and support integration of standalone systems with DeltaV DCS.
• Lead automation commissioning and Site Acceptance Testing (SAT) for facility and equipment upgrades.
• Manage and coordinate CQV (Commissioning, Qualification, and Validation) activities with cross-functional teams.
• Generate and execute validation documentation for DeltaV and Rockwell BAS systems, in compliance with GAMP5, 21 CFR Part 11, and EU Annex 11.
• Liaise with equipment vendors, internal stakeholders, and IT teams to implement upgrades and resolve system issues.
• Provide routine operational support for automation and control systems including during preventive maintenance and shutdown periods.
• Engage in incident resolution, root cause analysis, and implement corrective actions to maintain operational excellence.

Requirements:

• Minimum 8 years of experience in automation engineering with a strong focus on DeltaV DCS.
• Hands-on experience with validation and compliance for regulated environments (GMP, FDA, EU Annex 11).
• DeltaV DCS (Batch, Safety, Historian, Configuration, Administration)
• Rockwell BAS, SCADA, PLC (Allen-Bradley, Yokogawa, Invensys)
• Validation protocols: IQ, OQ, PQ, IOQ
• GAMP5, 21 CFR Part 11, EU Annex 11, ASTM E2500
• MES, OPC (DA, UA), Fieldbus, HMI systems
• SDLC & Change Control documentation
• Strong project management and stakeholder communication.
• Excellent analytical, troubleshooting, and documentation skills.
• Ability to lead cross-functional teams and train junior engineers.
• Familiarity with tools like Emerson’s Kneat Gx for paperless validation
• Willingness to support 24/7 operations and emergency response as required

Responsibilities:

• Provides expertise in performing Computerized Systems Validation.
• Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
• Perform collaborative work with the Compliance Engineering team on other CQV activities.
• Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
• Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
• Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
• Investigate deviations and write deviation reports and findings.
• Raise and follow-up change control records.

Requirements:

• Degree in Engineering/Science or related studies.
• Minimum of 4 years’ experience in relevant industry with at least 8 years in CSV, Quality Assurance, CQV, and Turnover Activities
• High level of understanding in Regulatory compliance
• Primarily responsible for supporting all computer validation aspects to the automation and engineering teams. This includes Domain Controller system (DCS), Manufacturing Execution system (MES), Manufacturing data warehouse (MDW), Building Automation Systems (BAS), GMP and non-GMP, Programmable Logic Controllers (PLC) based skids, IT infrastructure, standalone computerized system with equipment and validated spreadsheet.
• Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
• In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
• Works with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
• Develop Validation Master Plans (VMP), System Level Impact Assessments, and executed FAT, SAT, and Validation Protocols (IQ, OQ, PQ).
• Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier related to CSV
• Preferred who has training or Certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS

Responsibilities:

• Hands-on experience and understanding of automated systems supporting manufacturing, IT infrastructure, Engineering and operations.
• Strong understanding and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
•  Assist in review and preparation of process/production equipment validation and computer systems validation
• Review and approval of all Data Integrity – related activities and training including periodic reviews and status report to management
• Improve and add to existic Data Integrity knowledge base, identify training requirements and serve as SME for the same
• Serve as Validation Point of Contact and thus review all validation/qualification documents related to facilities, utilities and equipment.
• Train all site personnel in validation area, provide training and prepare for both internal and external audit and investigations that follow
• Hands on Computerized Systems Validation GAMP5/21CFR

Requirements:

• Minimum 5 years in Quality Management Systems and Proficient in leading Validation, Computerized Systems/SDLC, Change Management, Manufacturing Quality, Deviation Investigation, Data integrity, Audits and Compliance, Documentation Control, Training Management and CAPA management
• Minimum bachelor’s or master’s degree
• Preferred Six Sigma black and green belt certified as it is mandatory for the project prerequisite.
• GMP & GDP Certificate is mandatory
• Well versed with Regulatory Guidelines – USFDA, EU GMP, PDA, PICS, 21CFR, BPE, ISPE, USP <1050>, GAMP5, ISO, WHO etc.

Responsibilities:

• Provides expertise in performing Computerized Systems Validation.
• Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations (GxP, 21CFR11, etc.)
• Perform collaborative work with the Compliance Engineering team on other CQV activities.
• Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
• Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
• Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
• Investigate deviations and write deviation reports and findings.
• Raise and follow-up change control records.

Requirements:

• Degree in Engineering/Science or related studies.
• Minimum of 3 years to 4 years of’ experience in relevant industry with at least 3 years in CSV, Quality Assurance, CQV, and Turnover Activities
• High level of understanding in Regulatory compliance
• Primarily responsible for supporting all computer validation aspects to the automation and engineering teams. This includes Domain Controller system (DCS), Manufacturing Execution system (MES), Manufacturing data warehouse (MDW), Building Automation Systems (BAS), GMP and non-GMP, Programmable Logic Controllers (PLC) based skids, IT infrastructure, standalone computerized system with equipment and validated spreadsheet.
• Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
• In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
• Works with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities.
• Develop Validation Master Plans (VMP), System Level Impact Assessments, and executed FAT, SAT, and Validation Protocols (IQ, OQ, PQ).
• Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier related to CSV
• Preferred who has training or Certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS

Responsibilities:

• Hands-on experience and understanding of automated systems supporting manufacturing, IT infrastructure, Engineering and operations.
• Strong understanding and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
• Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
•  Assist in review and preparation of process/production equipment validation and computer systems validation
• Review and approval of all Data Integrity – related activities and training including periodic reviews and status report to management
• Improve and add to existic Data Integrity knowledge base, identify training requirements and serve as SME for the same
• Serve as Validation Point of Contact and thus review all validation/qualification documents related to facilities, utilities and equipment.
• Train all site personnel in validation area, provide training and prepare for both internal and external audit and investigations that follow
• Hands on Computerized Systems Validation GAMP5/21CFR

Requirements:

• Minimum 5 years in Quality Management Systems and Proficient in leading Validation, Computerized Systems/SDLC, Change Management, Manufacturing Quality, Deviation Investigation, Data integrity, Audits and Compliance, Documentation Control, Training Management and CAPA management
• Minimum bachelor’s or master’s degree
• GMP & GDP Certificate is plus
• Well versed with Regulatory Guidelines – USFDA, EU GMP, PDA, PICS, 21CFR, BPE, ISPE, USP <1050>, GAMP5, ISO, WHO etc.

Responsibilities:

1. Perform inspection of pressure vessel, piping including stage, final inspection and tank inspections.
2. Perform turn around inspection of pressure vessel, piping, tank and columns.
3. Able to review previous history, ITP, client procedures and NDT reports.
4. Perform corrosion monitoring inspection and coordination with NDT team
5. Submit daily and weekly reports to client on the inspection findings.
6. Perform QA/QC welding inspections at site.
7. To handle the QA/QC inspection activities in structural fabrication projects, skid manufacturer clients, pressure vessels, pipe spools etc
8. Knowledge of WPS/PQR and WQT tests.

Job requirements:

1. Must have bachelor or Diploma in mechanical engineering or equivalent
2. Must have more than 15 years’ work experience.
3. Must have valid API 510 and API 570 certificate. 
4. Must have NDT level II certificates in MPI, PT, UT and RT.
5. Must have previous shutdown inspection experience in Aster chemicals, Singapore.
6. Must have more than 30+ plant shutdown experience.
7. Knowledge in code book like AWS, ASME, API codes
8. Must have a good knowledge about MT, PT, UT, RT Methods.
9. Must having an inspection experience in Exchanger, pressure vessels, tanks and columns.