AUTOMATION SYSTEMS ENGINEER

ENSOFT CONSULTING PTE. LTD.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

ENSOFT CONSULTING PTE. LTD. is seeking an experienced Validation Engineer responsible for planning, executing, and documenting commissioning, qualification, and validation activities within a GMP environment.

You will support system lifecycle activities and ensure regulatory compliance while collaborating with cross-functional teams to deliver projects and achieve readiness. Responsibilities include IQ/OQ/PQ protocols, DeltaV testing, and ensuring alignment with URS/FS/DS and regulatory

Qualifications

• Bachelor's degree in engineering, IT, electronics or related technical discipline.
• 4+ years in CSV, commissioning & qualification, or validation in pharma/biotech/life sciences.
• Hands-on DeltaV DCS experience and related automation platforms.
• Strong GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity knowledge.

Responsibilities

• Execute commissioning and qualification activities for process equipment and associated systems.
• Develop, review, and execute IQ, OQ, PQ qualification protocols.
• Perform DeltaV functional testing and support system integration and validation activities.
• Verify operation against URS, FS, DS and GMP requirements.
• Coordinate with Engineering, Automation, Validation, QA, and Operations to resolve issues.

Skills

CSV

Commissioning

DeltaV DCS

Documentation

Cross-functional

Regulatory knowledge

Education

Bachelor's Degree in Engineering or related field

Tools

DeltaV

GMP documentation tools

Job description

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