Senior CSV Lead - DeltaV & GMP Validation

Valspec; San Francisco (CA); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

ESOP company

Premium medical coverage

401(k) with company match

Tuition reimbursement

Performance incentives

Job summary

Valspec is seeking a Senior Validation Consultant (CSV) to lead validation strategies for Emerson DeltaV DCS and GMP platforms in Northern California. You will drive CSV lifecycle activities, author critical documents, and coordinate cross-functional teams to ensure regulatory compliance and product quality.

The role emphasizes leadership, risk-based validation, data integrity, and collaboration with QA, manufacturing, and automation teams to deliver compliant validated systems on major

Qualifications

• Bachelor's degree and 10+ years of CSV experience in FDA-regulated environments
• Led validation programs for Emerson DeltaV DCS platforms
• Strong CSV lifecycle and risk-based validation knowledge
• Experience with GMP manufacturing systems and automation platforms
• Authoring/executing validation protocols and test documentation
• Understanding of GAMP 5, 21 CFR Part 11, and data integrity principles
• Experience with deviation management, CAPA and change control
• Ability to lead cross-functional teams and client-facing communications

Responsibilities

• Lead CSV activities for Emerson DeltaV DCS and GMP systems.
• Develop and execute validation strategies per FDA, GAMP 5, CFR 21 Part 11, Annex 11.
• Authors and reviews Validation Plans, VMPs, risk assessments, URS, FS, traceability, IQ/OQ, VSRs.
• Collaborate with automation and engineering teams to ensure lifecycle compliance.
• Review vendor FAT/SAT, testing records, and design deliverables.
• Lead validation execution and coordinate testing across stakeholders.
• Assess changes and support change control for validated systems.
• Support data integrity assessments and electronic records/signatures.
• Facilitate deviation investigations and remediation activities.
• Coordinate with C&Q, QA, Manufacturing and Automation teams.
• Track deliverables, schedules, milestones; report to leadership.
• Mentor junior validation engineers and contribute to planning.
• Engage in client discussions regarding validation scope and strategy.

Skills

Leadership

Regulatory knowledge

Cross-functional teamwork

Client-facing communication

Risk-based validation

Documentation rigor

GAMP 5 familiarity

Education

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

Tools

Emerson DeltaV DCS

OSI PI

SCADA/MES familiarity

Job description

Valspec is seeking a Senior Validation Consultant (CSV) to lead validation strategies for Emerson DeltaV DCS and GMP platforms in Northern California. You will drive CSV lifecycle activities, author critical documents, and coordinate cross-functional teams to ensure regulatory compliance and product quality.

The role emphasizes leadership, risk-based validation, data integrity, and collaboration with QA, manufacturing, and automation teams to deliver compliant validated systems on major