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Facilities Engineer Expert

1 week ago

Holly Springs, North Carolina, United States Insight Global Full time
Job Description

In this critical role, you will be part of the Facilities & Engineering (F&E) team at Insight Global, collaborating closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems for drug substance production.

Key Responsibilities
  • Own system performance for Biopharmaceutical process equipment, identifying opportunities for improvement or upgrades and developing business cases for implementation.
  • Develop and implement equipment maintenance programs, ensuring spare parts availability and coordinating activities to maintain optimal system functionality.
  • Ensure installed systems operate safely and comply with environmental health/safety practices, regulations, and rules.
  • Oversee commissioning and qualification processes in alignment with GMP requirements, interacting with regulatory inspectors as needed.
  • Provide system guidance to identify performance risks and implement mitigation strategies.
  • Pursue problem-solving initiatives to reduce production downtime through technical root cause analysis and corrective/preventive action implementation.
  • Support new product/technology introductions by conducting engineering assessments, implementing equipment modifications, and facilitating engineering runs.
Required Skills and Qualifications
  • 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.
  • Proven knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems.
  • Data-driven analytical skills and experience with techniques like Data Analytics, Root Cause Analysis, Statistical Process Control, Six Sigma, Predictive Maintenance.
  • Familiarity with regulated environments (cGMP, OSHA, EPA) and quality systems/processes.
  • Experience applying engineering principles to system modifications, process introduction, and capital project oversight.
  • Ability to travel domestically/internationally.
Preferred Qualifications
  • Master's Degree in Engineering or related field.
  • Clean and black utilities experience.
  • Commissioning, Qualification, and Validation experience.

This role requires a deep understanding of Biopharmaceutical process equipment and system design. If you are an experienced Facilities Engineer looking to make a significant impact, please consider this opportunity.