Senior Process Validation Engineer - PPQ & CPV Lead

United Pharma; California; On-site; USD 130,000 - 180,000; Full time

Job summary

United Pharma in Northern California seeks a Senior Process Validation Engineer to independently author and execute PPQ protocols, lead CPV activities, and own validation deliverables within a GMP drug substance setting.

The role collaborates with MSAT, Manufacturing, QA, and Process Development to align validation with production schedules and regulatory guidance, delivering right-first-time documentation on time.

Qualifications

• BS in a chemical/biochemical/biomedical or related technical field required.
• 8+ years of process validation experience in pharmaceutical/biotech GMP environments at senior/lead level.
• Hands-on authoring/executing PPQ protocols and reports.
• Working knowledge of the validation lifecycle and FDA guidance.
• Statistical analysis experience with Minitab or JMP.
• Strong GMP technical writing skills.
• Able to work onsite in Northern California from day one.

Responsibilities

• Author, execute, and report on PPQ protocols for drug substance manufacturing processes.
• Support the full process validation lifecycle—from Stage 1 (design) to Stage 3 (CPV).
• Develop and maintain control strategy elements, monitoring plans, and CPV trending.
• Perform statistical analysis of process data (capability, trending, limits) using Minitab or JMP.
• Author and review validation deviations, investigations, CAPAs, and change controls within GMP systems.
• Partner cross-functionally with MSAT/Manufacturing Sciences, Manufacturing, QA, and Process Development to align validation activities with schedules.
• Support process characterization and tech-transfer activities as needed.
• Ensure all work complies with FDA/ICH guidance and EU GMP Annex 15; maintain audit-ready documentation.

Skills

PPQ protocols

Statistical analysis

GMP documentation

Cross-functional teamwork

Technical writing

Minitab/JMP

Education

BS in Chemical Engineering

Tools

Minitab

JMP

MES/EBR systems

Job description

United Pharma in Northern California seeks a Senior Process Validation Engineer to independently author and execute PPQ protocols, lead CPV activities, and own validation deliverables within a GMP drug substance setting.

The role collaborates with MSAT, Manufacturing, QA, and Process Development to align validation with production schedules and regulatory guidance, delivering right-first-time documentation on time.