Kerja Sepenuh Masa, Computer System Validation Engineer (DeltaV) di Coalesce Management Consulting - Maukerja

We are seeking a Computer System Validation (CSV) Engineer with experience in Emerson DeltaV systems to support the validation and lifecycle management of automated and computerized systems within a regulated manufacturing environment. The successful candidate will be responsible for ensuring computerized systems are appropriately validated and maintained in compliance with applicable GMP requirements, data integrity principles and internal quality standards.

Key Responsibilities

• Develop, review and execute Computer System Validation documentation for DeltaV and other GMP computerized systems.
• Prepare validation deliverables including User Requirement Specifications (URS), Functional Specifications, Design Specifications, Risk Assessments, Validation Plans, IQ/OQ/PQ protocols, traceability matrices and validation reports.
• Perform risk-based validation activities throughout the system lifecycle.
• Support validation of DeltaV Distributed Control Systems (DCS), including system configuration, recipes, control modules, batch processes and associated interfaces.
• Review system configuration and automation documentation to ensure alignment with approved requirements and GMP expectations.
• Execute and document validation test scripts, including functional, security, alarm, audit trail and data integrity testing.
• Investigate and document validation deviations, discrepancies and test failures, and support resolution and CAPA activities.
• Support system changes through change control and assess the validation impact of software, hardware and configuration modifications.
• Support periodic reviews, system retirement and lifecycle documentation activities.
• Work closely with Automation, Engineering, IT, Quality Assurance, Manufacturing and vendors throughout project execution.
• Ensure computerized systems comply with relevant regulatory requirements and industry standards including GAMP 5, 21 CFR Part 11, EU Annex 11 and applicable data integrity requirements.
• Support regulatory inspections and internal or external audits when required.

Requirements

• Bachelor's Degree in Engineering, Computer Science, Information Technology, Pharmaceutical Sciences or a related discipline.
• Experience in Computer System Validation within pharmaceutical, biotechnology, medical device or other regulated manufacturing environments.
• Hands-on experience or strong working knowledge of Emerson DeltaV systems.
• Good understanding of the computerized system lifecycle and risk-based validation principles.
• Minimum 3-4 years of work experience with DeltaV