Senior Validation Engineer

Position Overview

We are seeking an experienced Process Validation Engineer to support a contract manufacturing facility specializing in gene therapy and oncology applications, including viral vector manufacturing. This position will provide technical leadership and subject matter expertise in the development, execution, and management of process validation activities across manufacturing operations.

The successful candidate will work cross-functionally with Manufacturing, Process Development, Analytical Development, Quality Control, Quality Assurance, and Project Management teams to ensure successful implementation and coordination of process validation activities.

The ideal candidate will have strong experience with cGMP manufacturing, process validation, Process Performance Qualification (PPQ), Continued Process Verification (CPV), commercial manufacturing, and FDA/regulatory submissions, including Biological License Application (BLA) filing experience.

Key Responsibilities

• Develop, review, and manage the execution of process validation activities.
• Provide technical leadership and serve as a Process Validation Subject Matter Expert (SME) for manufacturing unit operations.
• Develop and implement process validation frameworks and strategies.
• Implement consistent process qualification, process validation, and Continued Process Verification (CPV) strategies.
• Define strategies for Process Performance Qualification (PPQ) and product lifecycle management.
• Generate, review, and approve process validation protocols and reports.
• Design, schedule, execute, and evaluate scientifically and statistically sound qualification and validation studies.
• Ensure validation activities demonstrate that critical cleaning, controls, equipment, facilities, processes, and utilities operate consistently and repeatedly within established requirements.
• Lead studies involving process hold times, homogeneity, mixing, and other process-related parameters.
• Develop and support drug substance/API manufacturing process control strategies.
• Assess process performance through monitoring and analysis of process and product data.
• Lead process-validation-related investigations and technical assessments.
• Conduct complex validation impact assessments and develop robust scientific rationales.
• Write risk assessments to identify and evaluate potential risks associated with manufacturing processes and facility activities.
• Assist with creation and maintenance of process documentation to ensure production processing remains consistent with validated parameters.
• Monitor event and deviation trends to identify opportunities for proactive corrections and process improvements.
• Evaluate equipment and process problems and design appropriate testing to determine potential causes and solutions.
• Assist in determining process capability for new equipment.
• Ensure process development activities receive the necessary validation support.
• Provide validation support for new and existing manufacturing processes.
• Organize, manage, interpret, and analyze process validation and CPV data.
• Generate and maintain process validation and CPV documentation.
• Serve as a technical liaison between Process Development, Manufacturing, external manufacturers, suppliers, and other cross-functional teams.
• Independently manage smaller-scope validation engineering projects, including planning, execution, timelines, and deliverables.
• Act as a Process Validation SME during audits and customer meetings.
• Manage escalations within MSAT, customer, and project teams related to validation responsibilities and deliverables.
• Work closely with Manufacturing, Process Development, QC, QA, Operations, and Project Management to ensure scientific and CMC strategies are robust and maintained.
• Drive sound technical decision-making and collaborate with cross-functional teams to move projects forward.
• Manage multiple priorities in a fast-paced environment with changing business and project requirements.

Required Qualifications

• 7+ years of experience in a cGMP environment.
• Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, Life Sciences, or a related scientific/engineering discipline.
• 5+ years of experience with process validation, Process Performance Qualification (PPQ), and/or Continued Process Verification (CPV).
• Experience with Biological License Application (BLA) filing and interactions with the FDA and/or other regulatory agencies.
• Experience in commercial manufacturing.
• Experience managing and executing validation activities.
• Strong understanding of cGMP requirements and regulatory expectations.
• Strong technical writing, documentation, and communication skills.

Preferred Qualifications

• 10+ years of experience in manufacturing, process validation, PPQ, and CPV, with SME-level expertise.
• 5+ years of hands-on experience with cell culture upstream operations, including:
• Flask expansion
• Cell stacks
• Bioreactors
• Clarification
• Experience with downstream purification operations, including:
• TFF / UF-DF
• Automated chromatography skids
• AKTA
• XMO
• Sterile filtration
• Process development or manufacturing experience.
• Strong chemistry background.
• Expertise in both process development and manufacturing.
• Experience supporting gene therapy, viral vector, biologics, or other advanced manufacturing environments.

Technical & Professional Skills

• Process Validation
• Process Qualification
• Process Performance Qualification (PPQ)
• Continued Process Verification (CPV)
• Commercial Manufacturing
• cGMP
• BLA / FDA Regulatory Support
• Validation Protocols & Reports
• Risk Assessments
• Validation Impact Assessments
• Process Control Strategies
• Manufacturing Process Validation
• Data Analysis & Management
• Deviation/Investigation Support
• Technical Writing
• Cross-Functional Project Management
• Audit & Customer Support
• MSAT
• Process Development
• Upstream Processing
• Downstream Purification
• Cell Culture
• Bioreactors
• TFF / UF-DF
• Chromatography
• Sterile Filtration