Senior Process Validation Engineer - Onsite (Contract)

Valspec; Redwood City (CA); On-site; USD 103,000 - 117,000; Part time

Benefits offered by this job

Premium medical coverage

401(k) with company match

ESOP

Job summary

Valspec, a global provider of system validation and lifecycle services, seeks a Senior Process Validation Engineer (Contract) to support large-scale biologics drug substance manufacturing at a Northern California biotech site. This onsite engagement requires a senior candidate who can own PPQ and CPV deliverables with minimal ramp-up.

Role spans the full validation lifecycle from design through CPV, partnering with MSAT, Manufacturing, QA and Process Development in a GMP setting. Start ASAP.

Qualifications

• BS in Chemical, Biochemical, Biomedical Eng or related field.
• 8+ years of process validation in pharma/biotech GMP.
• Hands-on PPQ protocol authoring & execution.
• Knowledge of FDA process validation guidance.

Responsibilities

• Author, execute, and report PPQ protocols.
• Support lifecycle from design to CPV.
• Develop control strategies and CPV trending.
• Ensure GMP documentation readiness.

Skills

PPQ protocols

GMP writing

Statistical analysis

FDA process validation guidance

On-site work

Education

BS in Chemical/Biochemical/Biomedical Eng or related

Tools

Minitab

JMP

Job description

Valspec, a global provider of system validation and lifecycle services, seeks a Senior Process Validation Engineer (Contract) to support large-scale biologics drug substance manufacturing at a Northern California biotech site. This onsite engagement requires a senior candidate who can own PPQ and CPV deliverables with minimal ramp-up.

Role spans the full validation lifecycle from design through CPV, partnering with MSAT, Manufacturing, QA and Process Development in a GMP setting. Start ASAP.