Senior CSV Validation Lead

United Pharma; California; On-site; USD 150,000 - 210,000; Full time

Job summary

United Pharma seeks a Lead Validation Consultant to drive Computer System Validation for Emerson DeltaV DCS and GMP automation platforms. You will lead strategy, documentation, execution, and compliance while partnering with automation, quality, engineering, and manufacturing teams.

The role requires 10+ years in CSV within FDA-regulated environments, strong knowledge of GAMP 5, 21 CFR Part 11, data integrity, and proven leadership of validation programs.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline.
• 10+ years of Computer System Validation in FDA-regulated environments.
• Experience leading validation programs for Emerson DeltaV DCS platforms.
• Strong knowledge of the CSV lifecycle and risk-based validation methodologies.
• Experience with GMP manufacturing systems and automation platforms.

Responsibilities

• Lead CSV activities for Emerson DeltaV DCS and GMP systems.
• Develop and execute validation strategies per FDA, GAMP 5, 21 CFR Part 11, Annex 11, and company QA requirements.
• Author, review, and approve validation lifecycle documents (Plans, URS, FS, Traceability, IQ/OQ, Validation Summary).
• Coordinate testing and validation activities across multiple stakeholders and teams.
• Review vendor documentation, FAT/SAT, and design deliverables.
• Support data integrity assessments and validation activities for electronic records/e-signatures.
• Facilitate deviation investigations, impact assessments, and remediation related to validation deliverables.
• Mentor junior validation engineers and provide technical leadership.

Skills

CSV leadership

Regulatory compliance

GAMP 5

21 CFR Part 11

DeltaV DCS

Validation lifecycle

Documentation

Data integrity

Cross-functional leadership

Client-facing communication

Education

Bachelor's degree in Engineering/Computer Science/Life Sciences

Tools

DeltaV DCS

OSI PI

Rockwell/RSLogix

Job description

United Pharma seeks a Lead Validation Consultant to drive Computer System Validation for Emerson DeltaV DCS and GMP automation platforms. You will lead strategy, documentation, execution, and compliance while partnering with automation, quality, engineering, and manufacturing teams.

The role requires 10+ years in CSV within FDA-regulated environments, strong knowledge of GAMP 5, 21 CFR Part 11, data integrity, and proven leadership of validation programs.