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.
