Sr Associate Facilities

BioPharma Consulting JAD Group is seeking a Sr Associate Facilities to join our team. In this role, you will be responsible for managing and maintaining the facilities and equipment for our organization.

Responsibilities:

• Direct, plan, and delegate tasks for daily operations.
• Oversee corrective actions and preventive maintenance activities.
• Perform maintenance and emergency repairs on production-related utilities and facility equipment supporting GMP production, including: HVAC systems, HEPA certifications, Pressure cascades, Water purification systems, Plant and clean steam systems, Chillers and Clean gas systems
• Understand room classification and gowning requirements.
• Provide subject matter expertise for alarms and triage events impacting quality or safety.
• Utilize fundamental control system strategies and logic for troubleshooting.
• Analyze data trends from EMS/BMS/USC systems.
• Create, edit, or obsolete training materials related to equipment systems.
• Evaluate staff proficiency and maintain qualification records.
• Develop and maintain current repair job plans.
• Control spares inventory for associated equipment.
• Interact with support teams, including integrated contracted partners for calibration support.
• Manage relationships with external vendors providing contracted maintenance services.
• Ensure adherence to quality and safety change control procedures.
• Approve changes before execution.
• Follow CFRs, cGMPs, SOPs, and Amgen policies.
• Participate in on-call rotations for after-hours facility and manufacturing support.
• Be prepared to work outside established shift hours on short notice.

Requirements

Qualifications:

• Master's degree OR
• Bachelor's degree and 2 years of maintenance experience OR
• Associate’s degree and 6 years of maintenance experience OR
• High school diploma/GED and 8 years of maintenance experience

Preferred Qualifications:

• 2-year technical/AA/AS degree in building maintenance, mechanical maintenance, plant engineering, or a related technical discipline.
• 7+ years of combined education and experience, with 4+ years in an FDA (GMP) or comparable regulated environment.
• Experience with Root Cause Analysis (RCA) facilitation and participation.