Lead CSV Engineer

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

Lead Validation Consultant to support a major biopharmaceutical client This role will lead Computer System Validation (CSV) activities for Emerson DeltaV Distributed Control System (DCS) and associated GMP manufacturing and automation platforms.

The successful candidate will serve as the technical lead for validation strategy, documentation, execution, and compliance activities while working closely with automation, quality, engineering, and manufacturing teams. This individual will play a key role in ensuring validated systems meet regulatory expectations and support reliable GMP operations.

Responsibilities

• Lead Computer System Validation (CSV) activities for Emerson DeltaV DCS and supporting GMP systems.
• Develop and execute validation strategies in accordance with FDA, GAMP 5, 21 CFR Part 11, Annex 11, and company quality requirements.
• Author, review, and approve validation lifecycle documentation, including:
• Validation Plans
• User Requirements Specifications (URS)
• Functional Specifications
• Traceability Matrices
• IQ/OQ Protocols
• Validation Summary Reports
• Partner with automation and engineering teams to evaluate system designs and ensure compliance throughout the system lifecycle.
• Review vendor documentation, FAT/SAT documentation, testing records, and design deliverables.
• Lead validation execution activities and coordinate testing efforts across multiple stakeholders.
• Assess system changes and support change control activities for validated systems.
• Support data integrity assessments and validation activities associated with electronic records and electronic signatures.
• Facilitate deviation investigations, impact assessments, and remediation activities related to validation deliverables.
• Collaborate with Commissioning & Qualification (C&Q), Quality Assurance, Manufacturing, and Automation teams to ensure integrated project execution.
• Track validation deliverables, schedules, and project milestones while providing status updates to project leadership.
• Mentor junior validation engineers and provide technical leadership during project execution.
• Contribute to project planning, resource forecasting, and client-facing discussions regarding validation scope and strategy.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical discipline.
• 10+ years of Computer System Validation experience within FDA-regulated pharmaceutical, biotechnology, or life sciences 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
• FDA and global 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.

Preferred Qualifications

• Previous consulting experience supporting large pharmaceutical or biotechnology clients.
• Experience validating manufacturing automation systems, SCADA platforms, MES systems, historians, and integrated process controls.
• Familiarity with OSI PI, Syncade, Rockwell, Siemens, Honeywell, or related manufacturing systems.
• Experience supporting large capital projects, facility expansions, or new manufacturing sites.
• Proven ability to lead multiple validation workstreams simultaneously.