Process Validation Consultant

Overview

We are seeking an experienced Support Tech Transfer & Process Validation Specialist to support manufacturing science and technology activities related to process transfer, validation strategy development, and manufacturing readiness within a regulated biopharmaceutical environment.

This role will play a critical part in ensuring successful process transfer activities, validation execution, and readiness for commercial manufacturing while collaborating across multiple technical functions.

Key Responsibilities

• Define and implement process validation strategies to support manufacturing transfer activities
• Lead the identification and definition of studies required for process validation activities, including process performance qualification (PPQ) requirements
• Collect, review, and assess technical data from external and internal stakeholders to support validation activities
• Develop validation documentation including validation plans, comparability strategies, and associated technical documents
• Support manufacturing readiness activities to ensure successful execution of PPQ batch manufacturing
• Define validation requirements including variability assessment, acceptance criteria, testing strategy, and process prerequisites
• Support review and execution of validation studies including small-scale validation, impurity clearance studies, process hold times, mixing validation, shipping validation, and related activities
• Establish and support post-transfer comparability strategies
• Collaborate with Quality, Manufacturing, QC, and Technical Operations teams to ensure alignment across activities
• Assess operational readiness and support planning activities related to workload, timelines, and resource alignment
• Provide technical support across additional process validation and transfer activities as required

Candidate Profile

• Strong technical expertise in process validation and technology transfer activities
• Excellent analytical and problem-solving skills
• Strong stakeholder management and cross-functional communication abilities
• Comfortable working in complex, fast-paced environments with multiple priorities
• Detail-oriented with strong technical writing and documentation skills
• Collaborative mindset with strong project coordination capabilities

Experience & Requirements

• Extensive experience within biopharmaceutical, pharmaceutical, or biologics manufacturing environments
• Strong understanding of GMP / cGMP requirements and validation practices
• Experience supporting biological process transfer activities and manufacturing readiness initiatives
• Expertise in Process Performance Qualification (PPQ) and validation lifecycle activities
• Significant experience within validation, technical operations, manufacturing science, or related technical functions

What You’ll Bring

• Strong knowledge of process validation principles and lifecycle management
• Ability to translate technical data into validation strategies and actionable plans
• Experience supporting large-scale manufacturing transfer activities
• Commitment to quality, compliance, and continuous improvement