Full Time Senior Computer System Validation Engineer Jobs, in Coalesce Management Consulting - Maukerja

We are looking for an experienced Senior CSV Engineer to support the validation and qualification of Emerson DeltaV systems within a regulated pharmaceutical or biotechnology environment.

Key Responsibilities

• Plan, execute and document DeltaV CSV lifecycle activities.
• Prepare and review validation documentation including URS, FS, DS, Risk Assessments, IQ, OQ, PQ, Traceability Matrices and Validation Reports.
• Qualify DeltaV hardware infrastructure, software configurations, control modules, equipment modules and batch recipes.
• Support FAT, SAT, commissioning, qualification and regression testing activities.
• Ensure compliance with data integrity, audit trail, electronic signature, backup/restore and security requirements.
• Support deviations, change controls and discrepancy resolution.
• Collaborate with Automation, CQV, Quality, IT and Manufacturing teams.

Requirements

• Minimum 5 years of DeltaV CSV experience within pharmaceutical, biotechnology or other regulated life sciences environments.
• Strong experience in DeltaV hardware and software qualification.
• Good working knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11 and GMP Data Integrity requirements.
• Experience with IQ/OQ/PQ, FAT/SAT and validation documentation.