Sr Associate Facilities
Posted on Sep 21, 2024 by BioPharma Consulting JAD Group
Thousand Oaks, CA
Other
Immediate Start
Annual Salary
Contract/Project
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.
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.
Reference: 202105838
https://jobs.careeraddict.com/post/95494996
Sr Associate Facilities
Posted on Sep 21, 2024 by BioPharma Consulting JAD Group
Thousand Oaks, CA
Other
Immediate Start
Annual Salary
Contract/Project
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.
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.
Reference: 202105838
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