Coalesce Management Consulting
Singapore / Global
GET
The Big Jobsite
Singapore / Global
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.
Singapore / Global
Singapore / Global
Singapore / Global
Singapore / Global
Singapore / Global
Singapore / Global