DeltaV CSV Engineer

HTC Global Services; Singapore; On-site; SGD 90,000 - 140,000; Full time

Job summary

HTC Global Services seeks a DeltaV CSV Engineer with 5+ years of DeltaV CSV experience in GMP environments. You will drive qualification deliverables, IQ/OQ/PQ, risk assessments, and documentation across analytical lab equipment. Collaboration with QA, QC, Engineering, IT, and vendors ensures on-time milestones.

Responsibilities include CQV for analytical devices, HVAC/CQV topics, and interface testing with LIMS and historian systems where applicable, maintaining inspection-ready records.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, or related.
• Minimum 5 years of hands-on CQV experience with analytical or QC lab equipment in GMP-regulated environments.
• Strong GMP data integrity and ALCOA+ understanding.
• Experience authoring qualification protocols, risk assessments, deviations, and final reports.
• Excellent technical writing and stakeholder management.

Responsibilities

• Develop, review, and execute qualification protocols and lifecycle docs (IQ/OQ/PQ, risk assessments).
• Qualification of analytical and QC lab equipment (HPLC/UHPLC, GC, UV-Vis, TOC analyzers, etc.).
• Support FAT/SAT, calibration, installation verification, and handover.
• Plan temperature mapping for lab equipment.
• Verify data integrity features: audit trails, signatures, backups, time sync.
• Coordinate with QA, QC, Engineering, IT, vendors to meet milestones.
• Maintain inspection-ready GMP documentation.

Skills

DeltaV CSV

CQV/CSV experience

GMP data integrity

IQ/OQ/PQ documentation

Technical writing

Cross-functional coordination

Education

Bachelor’s degree in Engineering

Life Sciences or related discipline

GMP data integrity knowledge

Tools

Kneat

LIMS integration

OSI PI/AVEVA PI

Empower/Chromeleon CSV

Job description

About the Role

We are seeking an DeltaV CSV Engineer with minimum 5 years of DeltaV Computer System Validation (CSV) experience within pharmaceutical, biotechnology, or other GxP-regulated industries. Strong hands‑on experience in Emerson DeltaV validation and qualification activities.

Responsibilities

Analytical/QC Equipment CQV

• Develop, review, and execute qualification protocols and lifecycle documentation, including risk assessments, IQ, OQ, PQ, traceability matrices, discrepancy records, and summary reports.
• Perform commissioning and qualification of analytical and QC laboratory equipment, including HPLC/UHPLC, GC, UV-Vis spectrophotometers, TOC analyzers, dissolution systems, pH and conductivity meters, balances, incubators, ovens, refrigerators, and related laboratory systems.
• Support FAT, SAT, calibration, vendor documentation review, installation verification, and equipment handover activities.
• Plan and execute temperature mapping activities for laboratory-controlled temperature equipment where required.
• Verify computerized equipment controls and data‑integrity features, including audit trails, user access, security roles, electronic signatures, backup/restore, and time synchronization.
• Support interface and integration testing involving LIMS, chromatography data systems, PCS, MES, or historian platforms, where applicable.
• Manage deviations, CAPAs, change controls, punch‑list items, and discrepancy resolution through closure.
• Coordinate with QA, QC, Engineering, Automation, IT, vendors, and project stakeholders to meet qualification milestones.
• Maintain complete, inspection‑ready documentation in accordance with GMP and Good Documentation Practices.

Job Description

About the Role

We are seeking an DeltaV CSV Engineer with minimum 5 years of DeltaV Computer System Validation (CSV) experience within pharmaceutical, biotechnology, or other GxP-regulated industries. Strong hands‑on experience in Emerson DeltaV validation and qualification activities.

Responsibilities

Analytical/QC Equipment CQV

• Develop, review, and execute qualification protocols and lifecycle documentation, including risk assessments, IQ, OQ, PQ, traceability matrices, discrepancy records, and summary reports.
• Perform commissioning and qualification of analytical and QC laboratory equipment, including HPLC/UHPLC, GC, UV-Vis spectrophotometers, TOC analyzers, dissolution systems, pH and conductivity meters, balances, incubators, ovens, refrigerators, and related laboratory systems.
• Support FAT, SAT, calibration, vendor documentation review, installation verification, and equipment handover activities.
• Plan and execute temperature mapping activities for laboratory-controlled temperature equipment where required.
• Verify computerized equipment controls and data‑integrity features, including audit trails, user access, security roles, electronic signatures, backup/restore, and time synchronization.
• Support interface and integration testing involving LIMS, chromatography data systems, PCS, MES, or historian platforms, where applicable.
• Manage deviations, CAPAs, change controls, punch‑list items, and discrepancy resolution through closure.
• Coordinate with QA, QC, Engineering, Automation, IT, vendors, and project stakeholders to meet qualification milestones.
• Maintain complete, inspection‑ready documentation in accordance with GMP and Good Documentation Practices.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Chemistry, or a related discipline.
• Minimum 5 years of hands‑on CQV experience with analytical or QC laboratory equipment in pharmaceutical, biotechnology, or another GMP‑regulated environment.
• Strong understanding of equipment qualification lifecycle, GMP, ALCOA+ data‑integrity principles, and Good Documentation Practices.
• Demonstrated experience authoring and reviewing qualification protocols, risk assessments, deviations, and final reports.
• Strong technical writing, problem‑solving, planning, and cross‑functional stakeholder‑management skills.

Preferred / Advantageous

• Experience with chromatography data systems such as Empower or Chromeleon and associated CSV requirements.
• Knowledge of FDA, EU GMP, and PIC/S expectations for laboratory equipment and computerized systems.
• Experience supporting pharmaceutical or biotechnology manufacturing facilities and vendor‑led qualification activities.

DeltaV CSV

Key Responsibilities

• Plan and execute the DeltaV validation lifecycle, including validation strategy, risk assessment, requirements and design review, traceability, IQ, OQ, PQ, regression testing, and validation reporting.
• Author and review validation deliverables such as URS, FS, DS, risk assessments, traceability matrices, test protocols, discrepancy records, and validation summary reports.
• Qualify DeltaV hardware and infrastructure, including ProfessionalPLUS, Application and Operator Stations, M-Series/S-Series/PK controllers, CIOCs, I/O systems, network components, servers, and virtualized environments.
• Validate DeltaV software configuration and application functionality, including Control Modules, Equipment Modules, Unit Modules, batch phases, recipes, alarms, interlocks, graphics, interfaces, and security settings.
• Support design reviews, FAT, SAT, commissioning, qualification, system handover, and approved change implementation.
• Verify data‑integrity and compliance controls, including audit trails, user‑account management, security roles, electronic signatures, backup/restore, and time synchronization.
• Support cybersecurity and system‑hardening activities for validated DeltaV environments.
• Support validation of interfaces with MES, OSI PI/AVEVA PI historian, and other manufacturing systems, where applicable.
• Manage deviations, change controls, test discrepancies, vendor evidence, and validation documentation through closure.
• Coordinate closely with Automation, CQV, Quality, IT/OT, Manufacturing, and system‑integrator teams.

Requirements

• Bachelor’s degree in Engineering, Automation, Instrumentation, Computer Science, Pharmaceutical Technology, or a related technical discipline.
• Minimum 5 years of DeltaV CSV experience in pharmaceutical, biotechnology, or another GxP‑regulated environment.
• Proven experience qualifying DeltaV hardware infrastructure and validating DeltaV software modules and batch applications.
• Strong working knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, GMP data‑integrity requirements, and validation lifecycle documentation.
• Strong technical writing, test execution, discrepancy management, and stakeholder‑coordination skills.

Preferred / Advantageous

• CSV experience with PLC/HMI or SCADA platforms such as Siemens SIMATIC, WinCC, or SIMATIC Logon.
• Experience using electronic validation platforms such as Kneat.
• Exposure to system integration, industrial cybersecurity, virtual infrastructure, or OT network qualification.
• Knowledge of DeltaV qualification or CSV activities.

HVAC CQV

Key Responsibilities

• Develop, review, and execute HVAC and cleanroom qualification protocols, including IQ, OQ, PQ, requalification, discrepancy records, and final reports.
• Perform qualification of AHUs, HVAC systems, ducting, controls, HEPA filtration systems, temperature, humidity, differential‑pressure controls, and Grade C/D cleanrooms.
• Plan, execute, and review cleanroom certification testing, including airflow visualisation/smoke studies, air‑velocity measurements, air‑change calculations, HEPA filter integrity testing, non‑viable particle monitoring, room pressurisation verification, and temperature/humidity mapping.
• Support FAT, SAT, commissioning, startup, system balancing, punch‑list management, and handover activities.
• Review vendor and contractor documentation, test evidence, calibration records, and turnover packages.
• Manage deviations, change controls, punch‑list items, risk assessments, and qualification actions through closure.
• Coordinate with QA, Engineering, Operations, Automation, Facilities, contractors, and validation teams to achieve project milestones.
• Support verification of EMS/BMS monitoring and HVAC automation controls where they form part of the qualified system.
• Maintain accurate, inspection‑ready documentation in accordance with GMP and Good Documentation Practices.

Requirements

• Bachelor’s degree in Mechanical Engineering, Chemical Engineering, Building Services, or a related discipline.
• Minimum 5 years of HVAC and cleanroom CQV experience within pharmaceutical or biotechnology facilities.
• Strong knowledge of EU GMP Annex 1, ISO 14644 cleanroom standards, ISPE Baseline Guides, and Good Documentation Practices.
• Hands‑on experience with cleanroom qualification testing, HVAC control verification, deviations, and qualification reporting.
• Strong technical writing, troubleshooting, planning, and stakeholder‑management skills.

Preferred / Advantageous

• Experience with sterile manufacturing or aseptic‑processing environments, including isolators.
• Experience leading cleanroom qualification or requalification programmes.
• Familiarity with EMS/BMS systems and HVAC automation controls.

PLC/SCADA CSV

• Execute the CSV lifecycle for PLC and SCADA systems, including risk assessments, specification review, traceability, IQ, OQ, PQ, regression testing, and validation reporting.
• Qualify hardware infrastructure including PLCs, I/O systems, HMI terminals, SCADA servers and workstations, industrial networks, managed switches, and virtualized environments.
• Validate PLC software and control logic, including Ladder Logic, Function Block Diagrams, Structured Text, Sequential Function Charts, alarms, interlocks, sequences, and recipes.
• Validate SCADA applications including HMI graphics, alarm management, historian functionality, audit trails, security, electronic signatures, data collection, reporting, and system interfaces.
• Support FAT, SAT, commissioning, qualification, system handover, and approved changes.
• Verify data‑integrity and compliance controls, including user‑account management, security roles, electronic signatures, backup/restore, and time synchronization.
• Support industrial cybersecurity, system hardening, and validated infrastructure controls where applicable.
• Support integration and interface testing with MES, OSI PI/AVEVA PI historian, ERP, DCS, and package‑equipment systems.
• Manage deviations, change controls, test discrepancies, vendor evidence, and validation documentation through closure.
• Coordinate with Automation, CQV, Quality, IT/OT, Manufacturing, vendors, and system‑integrator teams.

Requirements

• Bachelor’s degree in Engineering, Automation, Electrical Engineering, Computer Science, or a related discipline.
• Minimum 5 years of PLC/SCADA CSV experience within pharmaceutical, biotechnology, medical‑device, or another GMP‑regulated environment.
• Proven experience qualifying automation hardware and validating PLC code and SCADA applications.
• Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11, GMP data‑integrity requirements, and validation lifecycle documentation.
• Experience with one or more PLC platforms such as Siemens, Allen‑Bradley/Rockwell, Schneider, or Mitsubishi.
• Experience with SCADA platforms such as WinCC, FactoryTalk, AVEVA/Wonderware, Ignition, or iFIX.
• Working knowledge of industrial communications such as OPC, Profinet, Profibus, Modbus TCP/IP, or EtherNet/IP.

Preferred / Advantageous

• Experience in GMP manufacturing, utilities, packaging, or process‑automation systems.
• CQV or commissioning experience and exposure to industrial cybersecurity/system hardening.
• Knowledge of DeltaV qualification or CSV activities.
• Experience using electronic validation platforms such as Kneat.