Quality Consulting Group, LLC
JT056 - SR. ASSOCIATE FACILITIES
Quality Consulting Group, LLC, Thousand Oaks, California, United States, 91362
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic individual to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:Provide maintenance leadership and technical expertise in support of facility equipment/systems, utility systems, and/or production suites, ensuring systems operate within designed parameters.Area of responsibility may consist of multiple facilities, disciplines, or clients. All work to be completed to assure minimal impact to production while complying with all safety / cGMP guidelines and Client's procedures.Directing, planning, and delegating tasks to personnel in daily operations, corrective action, and preventative maintenance activities in a reliable and compliant manner.Maintenance and emergency repair of all production-related utilities and facility equipment that supports GMP production: HVAC, HEPA certifications, and pressure cascades, water purification systems, plant and clean steam, chillers, and clean gas systems.Provide alarms and associated subject matter expertise to triage events impacting quality or safety.Understand fundamental control system strategy and logic to troubleshoot and provide data trends from EMS/BMS/USC systems.Create, edit, or obsolete training with associated equipment systems and evaluate staff proficiency to qualification records.Develop and maintain current repair job plans and spares inventory control for associated equipment.Interact with various support teams for integrated contracted partners for calibration support and outside vendors that provide contracted maintenance.Ensure quality and safety change control procedures are followed and changes are approved prior to execution and purchases being approved.Complete work in accordance with CFRs, cGMPs, SOPs, and policies.Participate in On-Call rotations for after-hours facility and Manufacturing support and may work outside of established shift hours upon short notice.Qualifications:2 year technical/AA/AS degree in building maintenance, mechanical maintenance, plant engineering, or related technical discipline.7+ years combined education and experience with 4+ years in an FDA (GMP) or comparable regulated environment.Experience with RCA facilitation and participation.Experience with RCM, TPM, or other reliability-centered concepts.Experience with installation, troubleshooting, maintenance, repair, and testing of HVAC, laboratory, and utilities equipment.Advanced knowledge of pneumatic, mechanical, and hydraulic fundamentals as well as advanced skills in the use of power and hand tools in the building trades such as carpentry, plumbing, and electrical.Available for On-Call rotations for after-hours facility support.Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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Responsibilities:Provide maintenance leadership and technical expertise in support of facility equipment/systems, utility systems, and/or production suites, ensuring systems operate within designed parameters.Area of responsibility may consist of multiple facilities, disciplines, or clients. All work to be completed to assure minimal impact to production while complying with all safety / cGMP guidelines and Client's procedures.Directing, planning, and delegating tasks to personnel in daily operations, corrective action, and preventative maintenance activities in a reliable and compliant manner.Maintenance and emergency repair of all production-related utilities and facility equipment that supports GMP production: HVAC, HEPA certifications, and pressure cascades, water purification systems, plant and clean steam, chillers, and clean gas systems.Provide alarms and associated subject matter expertise to triage events impacting quality or safety.Understand fundamental control system strategy and logic to troubleshoot and provide data trends from EMS/BMS/USC systems.Create, edit, or obsolete training with associated equipment systems and evaluate staff proficiency to qualification records.Develop and maintain current repair job plans and spares inventory control for associated equipment.Interact with various support teams for integrated contracted partners for calibration support and outside vendors that provide contracted maintenance.Ensure quality and safety change control procedures are followed and changes are approved prior to execution and purchases being approved.Complete work in accordance with CFRs, cGMPs, SOPs, and policies.Participate in On-Call rotations for after-hours facility and Manufacturing support and may work outside of established shift hours upon short notice.Qualifications:2 year technical/AA/AS degree in building maintenance, mechanical maintenance, plant engineering, or related technical discipline.7+ years combined education and experience with 4+ years in an FDA (GMP) or comparable regulated environment.Experience with RCA facilitation and participation.Experience with RCM, TPM, or other reliability-centered concepts.Experience with installation, troubleshooting, maintenance, repair, and testing of HVAC, laboratory, and utilities equipment.Advanced knowledge of pneumatic, mechanical, and hydraulic fundamentals as well as advanced skills in the use of power and hand tools in the building trades such as carpentry, plumbing, and electrical.Available for On-Call rotations for after-hours facility support.Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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