Head of Facilities and Engineering Operations

5 days ago


Gaithersburg, Maryland, United States Joulé Full time
Job Title: Head of Facilities and Engineering

We are seeking a highly experienced and skilled Head of Facilities and Engineering to join our team at Joulé. As a key member of our organization, you will be responsible for overseeing the day-to-day operations of our facilities and ensuring that all systems are in place to support our cGMP manufacturing operations.

Key Responsibilities:
  • Oversee the maintenance and upkeep of our 25,000 sq ft facility, including office, laboratory, and GMP cleanroom space.
  • Ensure compliance with cGMP regulations and maintain all necessary documentation.
  • Coordinate with contractors and vendors to achieve goals and objectives.
  • Manage the lifecycle of equipment and systems, including installation, operation, and maintenance.
  • Design review and criticality assessment, equipment installation and operation qualification, preventive maintenance and calibrations.
  • Ensure the operation and maintenance of HVAC systems supporting cGMP cleanrooms.
Requirements:
  • Bachelor's degree in a relevant discipline or equivalent experience.
  • Minimum 10 years of experience in a facilities and engineering role within the biotech/pharma sector, with a strong understanding of cGMP regulations.
  • Excellent troubleshooting, problem-solving skills, and attention to detail.
  • Proven ability to work effectively in a team environment and mentor junior staff.
  • Strong written and verbal communication skills.
Preferred Qualifications:
  • Thorough understanding of equipment lifecycle.
  • Working knowledge of typical bioprocess equipment and systems.
  • Familiarity with typical QC analytical equipment and cleanroom air classifications.
  • Proficient with building monitoring systems operations and alarm response.


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