Process Validation Engineer

Role:
Process Validation Engineer

Location:

North Carolina

We are seeking an experienced Process Validation Engineer to support multiple pharmaceutical manufacturing projects, with a primary focus on aseptic filling operations and pre-filled syringe (PFS) manufacturing. This role will be responsible for developing and executing validation strategies, supporting tech transfer initiatives, and ensuring compliant process implementation across new and existing manufacturing lines.

The ideal candidate will have strong expertise in process validation, aseptic processing, PPQ execution, media fills, smoke studies, and cGMP-regulated pharmaceutical manufacturing environments.

• Develop and execute process validation strategies for new and existing fill‑finish manufacturing lines.
• Lead Process Performance Qualification (PPQ) activities to demonstrate process consistency, reliability, and regulatory compliance.
• Support revalidation activities for pre‑filled syringe (PFS) filling lines and associated manufacturing processes.
• Coordinate, execute, and evaluate aseptic media fill studies to ensure process integrity and contamination control.
• Plan and conduct smoke studies to verify airflow patterns and aseptic processing conditions.
• Support technology transfer projects by implementing manufacturing processes across new and existing production lines.
• Collaborate with Manufacturing, Quality, Engineering, Validation, and external stakeholders to ensure successful project execution.
• Participate in risk assessments, protocol development, execution, deviation management, and final reporting.
• Support qualification activities for automated visual inspection systems and aseptic processing equipment.
• Ensure all validation documentation complies with cGMP, FDA, and regulatory requirements.

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Experience in pharmaceutical process validation within aseptic manufacturing environments.

Hands‑on experience with:

• Process Validation
• Process Performance Qualification (PPQ)
• Aseptic Media Fills
• Smoke Studies
• Technology Transfer
• Experience supporting pre‑filled syringe (PFS) manufacturing operations.

• Strong understanding of cGMP regulations and validation lifecycle activities.
• Excellent communication and cross‑functional collaboration skills.