Sr. Associate Facilities
1 month ago
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic 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, ensures 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/delegating of 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. - Alarms and associated subject matter expertise will be provided to triage events impact to quality or safety.
- Fundamental control system strategy and logic will need to be understood 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.
- Development and maintain the 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
- Assure quality and safety change control procedures are followed and changes are approved prior to execution and purchases being approved.
- Work to be completed in accordance with CFRs, cGMPs, SOPs and Amgen 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
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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