Job Orders

• Pharmaceutical Manufacturing

• Computer System Validation (CSV)
• Emerson DeltaV Distributed Control System (DCS)
• Pharmaceutical & Biotechnology Manufacturing
• Automation & Process Control Systems
• GAMP 5 / GxP Compliance
• IQ / OQ / PQ Validation
• MES & OSI PI Historian Integration
• Data Integrity & Cybersecurity

• Detail-oriented and quality-focused
• Strong analytical and problem-solving skills
• Excellent technical documentation skills
• Good communication and stakeholder management
• Able to work independently and within cross-functional teams
• Strong organizational and time management skills
• Compliance-driven with a proactive mindset

As a Computer System Validation (CSV) Engineer, you will be responsible for planning, executing, and documenting validation activities for Emerson DeltaV Distributed Control Systems (DCS), ensuring compliance with GxP, GAMP 5, FDA 21 CFR Part 11, EU Annex 11, and company quality standards.

Key Responsibilities

• Plan and execute the complete DeltaV Computer System Validation (CSV) lifecycle.
• Prepare, review and execute validation documentation including:

1. User Requirement Specifications (URS)
2. Functional Specifications (FS)
3. Design Specifications (DS)
4. Risk Assessments
5. Traceability Matrix
6. IQ, OQ & PQ Protocols
7. Validation Reports

• Perform qualification of DeltaV hardware infrastructure, including:

1. Professional Plus
2. Application & Operator Stations
3. M-Series, S-Series & PK Controllers
4. CIOCs & I/O Systems
5. Network Components
6. Virtual Environments

• Validate DeltaV software applications, system configurations and security settings.
  Review and test:

1. Control Modules (CM)
2. Equipment Modules (EM)
3. Unit Modules
4. Batch Phases & Recipes
5. Alarms, Interlocks & Graphics

• Execute and support:Factory Acceptance Test (FAT)

1. Site Acceptance Test (SAT)
2. Commissioning
3. IQ, OQ & PQ
4. Regression Testing

• Support integration with MES and OSI PI Historian.
• Ensure compliance with:

1. Data Integrity requirements
2. Audit Trails
3. Electronic Records & Electronic Signatures
4. User Access & Security Roles
5. Backup & Restore
6. Time Synchronization

• Support cybersecurity and system hardening activities.
• Manage deviations, discrepancies, change controls and validation deliverables.
• Participate in design reviews, risk assessments and change control reviews.
• Coordinate with Automation, CQV, Quality, IT, Manufacturing teams and external vendors throughout the project lifecycle.

• Computer Science
• Engineering
• Pharmaceutical Engineering
• Automation

• English

• English

• Others

• Bachelor’s Degree in Engineering, Computer Science, Automation, Instrumentation, Pharmaceutical Technology or a related technical discipline.
• Minimum 5 years of hands-on experience in DeltaV Computer System Validation (CSV).
• Minimum 5 years of validation experience within pharmaceutical, biotechnology or other regulated life sciences environments.
• Proven experience qualifying DeltaV hardware infrastructure and software modules.
• Strong knowledge of:

1. GAMP 5
2. FDA 21 CFR Part 11
3. EU Annex 11
4. GMP Data Integrity requirements

• Hands-on experience preparing and executing IQ, OQ, PQ protocols and validation documentation.
• Familiar with FAT, SAT, commissioning and change control processes.
• Experience integrating DeltaV with MES and OSI PI Historian is highly advantageous.
• Experience with CSV qualification of PLC/HMI systems (Siemens SIMATIC/WinCC) or SCADA/Siemens SIMATIC
• Logon will be an added advantage.
• Excellent documentation, analytical and communication skills.
• Able to work independently and collaborate effectively with cross-functional teams.