Senior Process Validation Engineer - Biotech Onsite

valspec; United States; On-site; USD 103,000 - 117,000; Part time

Job summary

Valspec is seeking a Senior Process Validation Engineer to support large-scale biologics drug substance manufacturing at a major biotech site in Northern California. This is a consulting engagement where you will own validation deliverables in GMP settings with minimal ramp-up.

You will author and execute PPQ protocols and lead CPV activities, working cross-functionally with MSAT, Manufacturing, QA, and Process Development to ensure right-first-time documentation and on-time execution.

Qualifications

• BS degree in a relevant technical field is required.
• Minimum 8+ years in process validation within pharma/biotech GMP environments.
• Hands-on authoring/execution of PPQ protocols and reports.
• Familiar with FDA process validation guidance and current GMP.
• Strong GMP technical writing and data analysis skills.

Responsibilities

• Author, execute, and report on PPQ protocols for drug substance manufacturing processes.
• Support the full process validation lifecycle—from design through CPV.
• Develop and maintain control strategy elements and CPV trending.
• Perform statistical analysis of process data (capability, trending, limits) using Minitab or JMP.
• Prepare validation deviations, investigations, CAPAs, and change controls in GMP systems.
• Collaborate with MSAT, Manufacturing, QA, and Process Development to align validation with production schedules.
• Support process characterization and tech-transfer activities as needed.
• Ensure compliance with FDA guidance, ICH Q8-Q12, and EU GMP Annex 15.

Skills

PPQ execution

CPV analysis

GMP documentation

Statistical analysis (Minitab/JMP)

Technical writing

Cross-functional collaboration

Education

BS in Chemical/ Biochemical/ Biomedical Engineering

Tools

Minitab

JMP

MES

Electronic batch records (eBR)

Job description

Valspec is seeking a Senior Process Validation Engineer to support large-scale biologics drug substance manufacturing at a major biotech site in Northern California. This is a consulting engagement where you will own validation deliverables in GMP settings with minimal ramp-up.

You will author and execute PPQ protocols and lead CPV activities, working cross-functionally with MSAT, Manufacturing, QA, and Process Development to ensure right-first-time documentation and on-time execution.