Job Description

Position Overview

The Process Validation Consultant will support biologics manufacturing activities with a primary focus on upstream and downstream process validation. This contract role is a backfill for a previous consultant and will play a critical role in executing process validation lifecycle activities, authoring key validation documentation, and supporting cross-functional teams during periods of heightened activity and audits.

This position is primarily onsite, with limited remote flexibility. Approximately 25% onsite presence is required to support audits and critical project milestones.

Key Responsibilities

• Execute process validation activities across the full validation lifecycle for biologics manufacturing
• Support upstream and downstream manufacturing processes, including chromatography operations and parameter evaluation
• Author and review validation documentation, including Validation Master Plans (VMPs), protocols, reports, risk assessments, and PFMEAs
• Perform data analysis and support validation studies for clinical phase manufacturing (Phase 1–3)
• Collaborate cross-functionally with manufacturing, quality, and technical operations teams
• Support regulatory inspections and internal audits during “pockets of intensity”
• Ensure validation activities are aligned with current regulatory expectations and industry best practices

Required Qualifications

• 5–10 years of experience in process validation within biologics manufacturing
• 5–10 years of hands-on experience authoring and executing Validation Master Plans (VMPs)
• Strong understanding of upstream and downstream biological processes
• In-depth knowledge of chromatography processes and critical parameter control
• Experience supporting validation activities across clinical phases (Phase 1, 2, and 3)
• Strong technical writing skills with the ability to produce clear, compliant documentation

Preferred Qualifications

• Experience supporting drug substance and/or drug product manufacturing
• Prior consulting or contract experience in regulated biologics environments

Soft Skills & Competencies

• Clear and effective verbal communication
• Strong technical writing and documentation skills
• Ability to work independently while integrating into an established team
• Comfortable working in fast-paced environments with fluctuating workloads

Contract Details

• Contract Length: 6 months, with potential for extension
• Schedule: 40 hours per week

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