Aseptic Lead, Operations - Dublin

Newyorkbioconnect

Dublin, Ireland
Hybrid
Aseptic operations
Sterile manufacturing
Contamination control
Lead the Environmental and Media Simulation Programs within the manufacturing area

Job Summary

  • Lead the Environmental and Media Simulation Programs within the manufacturing area.
  • Develop and implement the Aseptic qualification process within the department.
  • Ensure compliance with our company’s global policies, procedures, guidelines, and regulatory requirements, executing cGMP in daily activities.

Matching Summary

Lead the Environmental and Media Simulation Programs within the manufacturing area.

Skills & Requirements

Must-have

  • Aseptic Operations
  • Sterile Manufacturing
  • Contamination Control
  • Process Simulation
  • GMP Audit defense

Nice-to-have

  • Excellent communication skills
  • Planning and organization skills
  • Align team objectives with site goals

Key Requirements

  • Bachelor’s Degree or higher in Science, Engineering, or related technical discipline
  • Minimum of 5 years’ experience in Drug Product and sterile manufacturing operations
  • Experience with Media Simulations
  • Knowledge of sterile filling processes and equipment, particularly Grade A Isolator
  • Prior experience with GMP Audits

Work Rights

Not specified

Tailored Resume

Cover Letter