Sr Associate Facilities
1 month ago
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
- 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.
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