A Leader in Life science Manufacturing Technology solutions we are looking for top talent to be part of the dynamic team and drive the growth of the business.
CSV Consultant DeltaV Systems (36 Years)
Industry: Pharmaceutical / Biotech / Life Sciences
Experience: 36 Years
Engagement: Contract / Full-Time
Location: Site-based
Role Overview
We are seeking a CSV Consultant with 36 years of experience to support GxP-compliant DeltaV systems within pharmaceutical manufacturing environments. The role focuses on computer system validation (CSV) activities with a strong foundational understanding of DeltaV control systems including configuration control logic user access and security. The consultant will work closely with Automation Quality and IT teams to ensure compliant system delivery and lifecycle management.
Key Responsibilities
- Execute CSV activities across the system lifecycle (URS RA IQ OQ PQ Traceability Validation Reports).
- Support validation of DeltaV DCS systems including configuration verification and functional testing.
- Review and verify control logic batch configuration and alarm management from a CSV perspective.
- Validate user access management roles security settings and login controls in DeltaV.
- Support change control deviation handling and impact assessments for system updates.
- Participate in risk-based validation aligned with GAMP 5 and site CSV standards.
- Collaborate with Automation and Quality teams during testing execution and audits.
- Support regulatory inspections and internal audits as required.
Required Qualifications & Experience
- Bachelors degree in Engineering Computer Science or a related technical discipline.
- 36 years of hands-on experience in CSV within GxP-regulated environments.
- Fundamental understanding of Emerson DeltaV systems including:
- Control logic and configuration
- Batch concepts (ISA-88 awareness)
- User access security roles and audit trails
- Experience with regulated system validation documentation and execution.
- Good understanding of 21 CFR Part 11 data integrity and system security principles.
- Exposure to GMP pharmaceutical manufacturing operations.
A Leader in Life science Manufacturing Technology solutions we are looking for top talent to be part of the dynamic team and drive the growth of the business. CSV Consultant DeltaV Systems (36 Years) Industry: Pharmaceutical / Biotech / Life Sciences Experience: 36 Years Engagement: Contract / Ful...
A Leader in Life science Manufacturing Technology solutions we are looking for top talent to be part of the dynamic team and drive the growth of the business.
CSV Consultant DeltaV Systems (36 Years)
Industry: Pharmaceutical / Biotech / Life Sciences
Experience: 36 Years
Engagement: Contract / Full-Time
Location: Site-based
Role Overview
We are seeking a CSV Consultant with 36 years of experience to support GxP-compliant DeltaV systems within pharmaceutical manufacturing environments. The role focuses on computer system validation (CSV) activities with a strong foundational understanding of DeltaV control systems including configuration control logic user access and security. The consultant will work closely with Automation Quality and IT teams to ensure compliant system delivery and lifecycle management.
Key Responsibilities
- Execute CSV activities across the system lifecycle (URS RA IQ OQ PQ Traceability Validation Reports).
- Support validation of DeltaV DCS systems including configuration verification and functional testing.
- Review and verify control logic batch configuration and alarm management from a CSV perspective.
- Validate user access management roles security settings and login controls in DeltaV.
- Support change control deviation handling and impact assessments for system updates.
- Participate in risk-based validation aligned with GAMP 5 and site CSV standards.
- Collaborate with Automation and Quality teams during testing execution and audits.
- Support regulatory inspections and internal audits as required.
Required Qualifications & Experience
- Bachelors degree in Engineering Computer Science or a related technical discipline.
- 36 years of hands-on experience in CSV within GxP-regulated environments.
- Fundamental understanding of Emerson DeltaV systems including:
- Control logic and configuration
- Batch concepts (ISA-88 awareness)
- User access security roles and audit trails
- Experience with regulated system validation documentation and execution.
- Good understanding of 21 CFR Part 11 data integrity and system security principles.
- Exposure to GMP pharmaceutical manufacturing operations.
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