Lead CSV Validation Engineer – DeltaV & GMP Systems

Valspec; Foster City (CA); Hybrid; USD 130.000 - 170.000; Vollzeit

Zusammenfassung

Valspec is seeking an experienced Lead Validation Consultant to support a major biopharmaceutical client in Northern California. This role will lead Computer System Validation activities for Emerson DeltaV DCS and associated GMP manufacturing 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 to ensure validated

Qualifikationen

• 10+ years of Computer System Validation experience in FDA-regulated environments.
• Demonstrated experience leading validation programs for Emerson DeltaV DCS.
• Experience authoring and executing validation protocols and test documentation.
• Strong knowledge of GAMP 5, 21 CFR 11, Data Integrity, and regulatory requirements.
• Experience with deviation management, CAPA, and change control processes.

Aufgaben

• Lead CSV activities for Emerson DeltaV DCS and GMP systems.
• Develop and execute validation strategies per FDA and GMP guidelines.
• Author, review, and approve validation lifecycle documents (URS, FDS, IQ/OQ, VMPs).
• Collaborate across automation, quality, engineering, and manufacturing teams.
• Coordinate testing across stakeholders and manage validation milestones.
• Mentor junior validation engineers and provide technical leadership.

Kenntnisse

Cross-functional leadership

Client-facing communication

Project leadership

Mentoring

Strategic problem solving

Ausbildung

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

Tools

OSI PI

Syncade

Rockwell

Siemens

Honeywell

Jobbeschreibung

Valspec is seeking an experienced Lead Validation Consultant to support a major biopharmaceutical client in Northern California. This role will lead Computer System Validation activities for Emerson DeltaV DCS and associated GMP manufacturing 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 to ensure validated