Lead CSV Validation Engineer for GMP DCS Systems

United Pharma; Los Angeles (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Health insurance

401(k)

Paid time off

Job summary

United Pharma seeks a senior validation lead to drive Computer System Validation (CSV) for Emerson DeltaV DCS and GMP platforms. You will shape validation strategy, author critical documentation, and coordinate cross-functional testing with automation, quality, engineering, and manufacturing teams.

The role requires extensive CSV experience, regulatory knowledge (GAMP 5, 21 CFR Part 11), and strong leadership skills to ensure compliant, 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.
• Demonstrated 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.
• Strong understanding of GAMP 5, 21 CFR Part 11, Data Integrity principles, and regulatory requirements.
• Experience with deviation management, CAPA, and change control processes.
• Ability to lead cross-functional teams and influence project stakeholders.
• Excellent written, verbal, and client-facing communication skills.

Responsibilities

• Lead Computer System Validation (CSV) activities for Emerson DeltaV DCS and GMP systems.
• Develop and execute validation strategies in compliance with FDA, GAMP 5, 21 CFR Part 11, Annex 11.
• Author, review, and approve validation lifecycle documentation (URS, FS, IQ/OQ, etc.).
• Coordinate testing across stakeholders and review vendor FAT/SAT docs.
• Mentor junior validation engineers and provide technical leadership.
• Track deliverables, schedules, and milestones; report status to leadership.
• Support data integrity assessments and validation activities for electronic records/signatures.
• Collaborate with C&Q, QA, Manufacturing, and Automation teams on project execution.
• Manage deviations, CAPA, and change control related to validation.

Education

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline

Tools

OSI PI

Syncade

Rockwell

Siemens

Honeywell

Job description

United Pharma seeks a senior validation lead to drive Computer System Validation (CSV) for Emerson DeltaV DCS and GMP platforms. You will shape validation strategy, author critical documentation, and coordinate cross-functional testing with automation, quality, engineering, and manufacturing teams.

The role requires extensive CSV experience, regulatory knowledge (GAMP 5, 21 CFR Part 11), and strong leadership skills to ensure compliant, reliable GMP operations.