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Engineering Infrastructure Manager

1 week ago

Holly Springs, North Carolina, United States Insight Global Full time
About the Role

We are seeking a highly skilled Facilities Engineer to join our team at Insight Global. As a key member of our Facilities & Engineering group, you will collaborate with the corporate engineering team to design, build, commission, and qualify new equipment and systems for drug substance production.

Responsibilities
  • Design and implement system improvements, ensuring compliance with GMP requirements.
  • Collaborate with the engineering team to develop and implement equipment maintenance programs.
  • Conduct risk assessments to identify potential issues and develop mitigation strategies.
  • Implement equipment modifications to support new product introductions.
  • Interact with regulatory inspectors during qualification and commissioning processes.
  • Pursue initiatives to reduce production downtime through technical root cause analysis and corrective/preventive action implementation.
Requirements
  • Bachelor's Degree in Engineering or related field.
  • 6+ years of experience in Process/Facilities Engineering.
  • 5+ years of experience in a pharmaceutical or biopharmaceutical manufacturing environment.
  • Knowledge of GMP Biopharmaceutical Production facility equipment/systems.
  • Analytical skills and experience with data-driven techniques.
  • Familiarity with regulated environments and quality systems/processes.
  • Experience applying engineering principles to system modifications and capital project oversight.
  • Domestic/international travel ability.

A successful candidate will have a strong technical background and excellent collaboration skills.