Senior Validation Engineer

United Pharma; California; Presencial; USD 140 000 - 190 000; Tempo integral

Resumo da oferta

United Pharma is seeking an experienced Senior Validation Consultant (CSV) to lead Computer System Validation activities for Emerson DeltaV DCS and related GMP manufacturing systems in Northern California.

This role provides technical leadership across validation strategy, documentation, execution, compliance, and cross-functional coordination to ensure computerized systems meet regulatory and GMP requirements.

Qualificações

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related technical discipline.
• 10+ years of Computer System Validation (CSV) experience in FDA-regulated pharmaceutical, biotechnology, or life sciences environments.
• Strong hands-on experience with Emerson DeltaV DCS validation.
• Proven experience leading CSV strategy, execution, documentation, and compliance activities.
• Strong knowledge of GAMP 5, 21 CFR Part 11, Data Integrity, and risk-based validation methodologies.

Responsabilidades

• Lead CSV activities for Emerson DeltaV DCS and supporting GMP manufacturing systems.
• Develop and execute risk-based validation strategies aligned with FDA requirements, GAMP 5, 21 CFR Part 11, and applicable global regulations.
• Author, review, and maintain validation lifecycle documentation, including Validation Plans, VMPs, URS, Functional Specifications, Risk Assessments, Traceability Matrices, IQ/OQ protocols, and Validation Summary Reports.
• Partner with Automation, Engineering, Quality, Manufacturing, and C&Q teams throughout the system lifecycle.
• Review vendor documentation, FAT/SAT records, testing documentation, specifications, and design deliverables.
• Lead validation execution activities and coordinate testing across multiple project stakeholders.
• Evaluate system changes and support change control activities for validated systems.
• Support data integrity assessments and validation activities involving electronic records and electronic signatures.

Conhecimentos

CSV leadership

Regulatory compliance

Technical writing

Cross-functional coordination

GAMP 5 knowledge

FDA regulations

Formação académica

Bachelor’s degree in Engineering, Computer Science, Life Sciences

Ferramentas

Emerson DeltaV DCS

Descrição da oferta de emprego

We are seeking an experienced Senior Validation Consultant (CSV) to support a major biopharmaceutical client in Northern California. This role will lead Computer System Validation (CSV) activities for Emerson DeltaV DCS and associated GMP manufacturing and automation systems. The ideal candidate will provide technical leadership across validation strategy, documentation, execution, compliance, and cross-functional coordination while ensuring computerized systems meet regulatory and GMP requirements.

Key Responsibilities:

• Lead Computer System Validation (CSV) activities for Emerson DeltaV DCS and supporting GMP manufacturing systems.
• Develop and execute risk-based validation strategies aligned with FDA requirements, GAMP 5, 21 CFR Part 11, and applicable global regulations.
• Author, review, and maintain validation lifecycle documentation, including Validation Plans, VMPs, URS, Functional Specifications, Risk Assessments, Traceability Matrices, IQ/OQ protocols, and Validation Summary Reports.
• Partner with Automation, Engineering, Quality, Manufacturing, and C&Q teams throughout the system lifecycle.
• Review vendor documentation, FAT/SAT records, testing documentation, specifications, and design deliverables.
• Lead validation execution activities and coordinate testing across multiple project stakeholders.
• Evaluate system changes and support change control activities for validated systems.
• Support data integrity assessments and validation activities involving electronic records and electronic signatures.

Skills & Qualifications:

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.
• 10+ years of Computer System Validation (CSV) experience within FDA-regulated pharmaceutical, biotechnology, or life sciences environments.
• Strong hands-on experience with Emerson DeltaV DCS validation.
• Proven experience leading CSV strategy, execution, documentation, and compliance activities.
• Strong knowledge of GAMP 5, 21 CFR Part 11, Data Integrity, and risk-based validation methodologies.
• Experience with URS, Functional Specifications, Risk Assessments, Traceability Matrices, IQ/OQ, and Validation Summary Reports.
• Strong understanding of GMP manufacturing systems and automation platforms.
• Experience managing deviations, CAPA, change controls, and remediation activities.
• Strong technical writing, documentation, problem-solving, and communication skills.