Lead CSV Engineer

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
• Validation Master Plans (VMPs)
• Risk Assessments
• 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.