Sr. Validation Engineer

Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Location: Northern California (Onsite/Hybrid Based on Project Requirements)

Valspec is a leading provider of engineering, validation, and lifecycle services to the life sciences industry. We partner with some of the world's most innovative pharmaceutical and biotechnology companies to deliver projects that improve manufacturing performance, product quality, and patient outcomes. Our consultants work at the forefront of digital manufacturing, automation, validation, and regulatory compliance.

Valspec is seeking an experienced Lead Validation Consultant to support a major biopharmaceutical client in Northern California. 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.

• 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.

• 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…