Process Validation Engineer

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

Senior Process Validation Engineer (Consultant) - Contract

Engagement: Valspec consultant placed onsite at a biotech manufacturing site in Northern California.

Location: Northern CA (onsite)

Type: Contract / consulting - initial term approximately 6-7 months, with a strong likelihood of extension

Start: ASAP

About the Engagement

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 supporting an active validation effort, so we need a senior-level candidate who can hit the ground running - owning validation deliverables independently in a GMP environment with minimal ramp-up.

Why this engagement stands out:

High-visibility validation work at a major biotech site.

Initial 6-7 month term with a strong likelihood of extension (not guaranteed, but the work pipeline points that way).

Role Overview

The Senior Process Validation Engineer will independently author and execute process validation deliverables across the validation lifecycle, partnering closely with Manufacturing Sciences (MSAT), Manufacturing, Quality, and Process Development. As a senior individual contributor, this person is expected to own deliverables with minimal oversight and drive cross-functional alignment. The role centers on Process Performance Qualification (PPQ) and Continued Process Verification (CPV) for commercial drug substance processes, with an emphasis on right-first-time documentation and on-time execution.

Key Responsibilities

• Author, execute, and report on PPQ protocols for drug substance manufacturing processes.
• Support the full process validation lifecycle - Stage 1 (process design) through Stage 2 (PPQ) and Stage 3 (Continued Process Verification).
• Develop and maintain control strategy elements, process 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 quality systems.
• Partner cross-functionally with MSAT/Manufacturing Sciences, Manufacturing, QA, and Process Development to align validation activities with production schedules.
• Support process characterization and tech-transfer activities as needed.
• Ensure all work complies with FDA process validation guidance, ICH Q8-Q12, and EU GMP (Annex 15).
• Maintain accurate, audit-ready GMP documentation and validation records.

Required Qualifications

• BS in Chemical, Biochemical, or Biomedical Engineering, Biology, Biochemistry, or a related technical field.
• 8+ years of process validation experience in a pharmaceutical or biotech GMP manufacturing environment, at a senior/lead level.
• Hands-on experience authoring and executing PPQ protocols and reports.
• Working knowledge of the process validation lifecycle and current FDA process validation guidance.
• Statistical analysis experience using Minitab or JMP.
• Strong GMP technical writing skills.
• Able to work onsite in Northern California and be fully productive from day one given the short engagement window.

Preferred Qualifications

• Large-scale biologics drug substance experience (mammalian cell culture and downstream purification).
• Prior experience at a large-scale commercial biologics manufacturer.
• Familiarity with relevant unit operations: bioreactors, chromatography, UF/DF, viral filtration.
• Experience with electronic batch records / MES and validation lifecycle management systems.
• Tech-transfer experience.

What Makes a Strong Fit for This Engagement

Because this is a focused, senior-level engagement, the ideal candidate is a career consultant or contractor who has owned PPQ campaigns end-to-end and can be fully productive almost immediately - there isn't runway for a long ramp. Prior large-scale biologics drug substance experience and recent contract history are strong positive signals. Local or relocation-ready candidates are preferred given the onsite requirement in Northern California.

Join Us

Salary Range: $75 - $85 / hourly range is an estimate of pay for project-based employment. Range varies based on knowledge and experience. Higher rates possible for short-term assignments and independent contractors. If you are a dedicated Process Engineer with a