Lead CSV Validation Consultant – GMP Life Sciences

Valspec; Makkah Region; Hybrid; SAR 562,000 - 787,000; Full time

Benefits offered by this job

Premium medical coverage

401(k) with company match

ESOP program

Job summary

Valspec is seeking an experienced Lead Validation Consultant to support a major biopharmaceutical client in Northern California. You will lead Computer System Validation activities for Emerson DeltaV DCS and GMP platforms, serving as the technical lead for validation strategy, documentation, and compliance.

You will collaborate with automation, quality, engineering, and manufacturing teams to ensure validated systems meet regulatory expectations and support reliable GMP operations.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline.
• 10+ years of Computer System Validation experience within FDA-regulated environments.
• Experience leading validation programs for Emerson DeltaV DCS platforms.
• Strong knowledge of the CSV lifecycle and risk-based validation methodologies.
• Experience supporting GMP manufacturing systems and automation platforms.
• Direct experience authoring and executing validation protocols and test documentation.
• Familiar with GAMP 5, 21 CFR Part 11, and data integrity principles.

Responsibilities

• Lead validation activities for CSV projects and coordinate testing across stakeholders.
• Develop and execute validation strategies adhering to FDA, GAMP 5, 21 CFR Part 11, Annex 11, and internal requirements.
• Author, review, and approve validation lifecycle documentation (URS, VMPs, IQ/OQ, etc.).
• Partner with automation and engineering teams to ensure design and lifecycle compliance.
• Review vendor FAT/SAT documents and testing records.
• Track validation deliverables, schedules, and project milestones; provide status updates.

Skills

Leadership

Cross-functional collaboration

Client-facing communication

Regulatory compliance

Risk-based validation

Validation execution

Troubleshooting

Education

Bachelor's degree in Engineering/CS/Life Sciences

Tools

Emerson DeltaV DCS

OSI PI

Rockwell

Siemens

Honeywell

Job description

Valspec is seeking an experienced Lead Validation Consultant to support a major biopharmaceutical client in Northern California. You will lead Computer System Validation activities for Emerson DeltaV DCS and GMP platforms, serving as the technical lead for validation strategy, documentation, and compliance.

You will collaborate with automation, quality, engineering, and manufacturing teams to ensure validated systems meet regulatory expectations and support reliable GMP operations.