Senior Engineering Professional

6 days ago


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

We are seeking a seasoned Facilities Engineer to join our Insight Global team. In this position, you will play a crucial role in designing, building, commissioning, and qualifying new equipment and systems for drug substance production.

Responsibilities
  • System ownership: Identify areas for improvement and develop business cases for upgrade implementation.
  • Maintenance program development: Ensure spare parts availability and coordinate activities to maintain optimal system functionality.
  • Safety compliance: Ensure installed systems operate safely and comply with environmental health/safety practices, regulations, and rules.
  • Qualification and commissioning: Oversee processes in alignment with GMP requirements, interacting with regulatory inspectors as needed.
  • Risk management: Provide system guidance to identify performance risks and implement mitigation strategies.
  • Problem-solving: Pursue initiatives to reduce production downtime through technical root cause analysis and corrective/preventive action implementation.
  • New product introductions: Support product launches by conducting engineering assessments, implementing equipment modifications, and facilitating engineering runs.
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.

The ideal candidate will possess strong technical expertise and excellent collaboration skills.



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