Senior Validation Engineer – Aseptic Processing | GMP Manufacturing

We're partnering with an innovative organization at the forefront of cell and gene therapy manufacturing to find a Senior Validation Specialist/Aseptic Filling Technician
.

This is an exciting opportunity to join a growing team supporting sterile manufacturing operations and helping bring life-changing therapies to patients.

If you have experience with aseptic processing, validation, and GMP manufacturing and enjoy working in a collaborative, fast-paced environment, we'd love to connect!

• Lead and support aseptic process simulations (Media Fills).
• Execute and support process validation activities for sterile manufacturing.
• Develop, review, and execute validation protocols and reports.
• Collaborate with Manufacturing, Quality, Engineering, and Microbiology teams.
• Investigate deviations and implement CAPAs.
• Support contamination control and environmental monitoring initiatives.
• Ensure compliance with FDA, cGMP, and regulatory requirements.
• Participate in continuous improvement projects to optimize manufacturing processes.

• Bachelor's degree in Engineering, Biology, Chemistry, Pharmaceutical Sciences, or a related scientific field.
• Experience in GMP pharmaceutical, biologics, or cell & gene therapy manufacturing
  .
• Hands-on experience with Media Fill (Aseptic Process Simulation).
• Experience with process validation
  , IQ/OQ/PQ
  , PPQ
  , or related validation activities.
• Knowledge of aseptic manufacturing, contamination control, and cleanroom operations.
• Experience with deviations, CAPAs, and change control.
• Strong communication and cross-functional collaboration skills.

• Work on cutting-edge therapies that make a real difference in patients' lives.
• Join a collaborative and innovative manufacturing environment.
• Competitive compensation and comprehensive benefits.
• Career growth opportunities within a rapidly expanding organization.