Senior Validation Engineer

Job overview

The Senior Validation Engineer role is onsite in Fremont, CA; the description also identifies Northern California project work as onsite or hybrid depending on project requirements. Compensation is not specified. Valspec provides validation and lifecycle services to life sciences clients, supporting systems used in regulated manufacturing and therapy production. The role leads computer system validation activities and documentation for GMP systems, helping ensure systems meet regulatory expectations and support reliable manufacturing operations. It coordinates validation execution with quality, automation, engineering, and manufacturing stakeholders.

What you'll do

• Lead Computer System Validation activities for Emerson DeltaV DCS and supporting GMP systems
• develop and execute validation strategies
• author, review, and approve lifecycle documentation
• assess system designs and vendor documentation
• coordinate testing
• support change control, data integrity, deviations, and remediation
• track deliverables and milestones
• mentor junior validation engineers
• contribute to planning and client discussions.

What we're looking for

Skills & competencies

senior validation engineer

computer system validation

fremont ca

valspec

emerson deltav

gmp

life sciences

21 cfr part 11

gamp 5

validation documentation

regulatory compliance

data integrity

Work arrangement

• Weekend coverage required

Benefits & perks

• Employee Stock Ownership Plan, premium medical coverage, 401(k) with company match, tuition reimbursement, and performance incentives.

Why this role

The description calls the role Senior Validation Consultant (CSV) and Lead Validation Consultant, requiring 10+ years of CSV experience and demonstrated leadership of Emerson DeltaV DCS validation programs. Candidates must be legally eligible to work in the United States without company sponsorship.

About the employer

Valspec is hiring for this role. Industry: Engineering Services. Sector: 54.