GMP Maintenance Technician II

About AGC Biologics  
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  

 

JOB SUMMARY 

The Maintenance Technician II is responsible for executing, maintaining and improving the cGMP equipment PM Program at AGC Biologics facilities. This is a key position that ensures the reliability of equipment for new Bio-Manufacturing Facility as well as maintaining the current operation of the existing facilities. 

 

ESSENTIAL JOB DUTIES/RESPONSIBILITIES 

• Perform basic preventative maintenance work on complex manufacturing equipment such as bioreactors, processing pumps, valves, RO/DI water systems, distillation systems, distribution systems, steam generation, compressed air systems and other manufacturing and utility system equipment. 
• Assist in troubleshooting, installations and repairs of complex instrumentation on production, laboratory and facility systems, ensuring all systems and devices are calibrated in accordance with manufacturer's specifications and AGC Biologics internal SOP's. 
• Maintain a safe work environment; work in a safe manner following all safety SOP's and wear Personal Protective Equipment as required. 
• Maintain assigned area of ownership within the facility to support inspection readiness and general facility upkeep for support of clinical and commercial manufacturing. 
• Complete maintenance work orders within the allotted time. 
• Maintain all assigned maintenance records, work orders, and investigations in an orderly and accurate manner in compliance with cGMP's by the utilization of the site CMMS and Document Management Systems. 
• Assist Equipment Owners determine the appropriate maintenance information for their processes through the evaluation of equipment specifications. 
• Assist in qualification activities related to Instrumentation and Process improvement projects. 
• Escort and or assist with Vendors who may perform maintenance on site, and Interface with maintenance contractors, ensuring work is compliant with AGC SOP's and cGMP's within the facility. 
• Assist in the review and development of Maintenance Department Procedures. 
• Ensure compliance with all applicable regulatory agencies including FDA, OSHA, CFR, etc. 

 

LEADERSHIP SKILLS 

• Good written, verbal and interpersonal communications skills. 
• Demonstrated good interpersonal skills, customer focus, and professionalism. 

• Ability to work quickly and effectively without constant supervision. 
• Ability to work in a fast-paced environment. 

 

QUALIFICATIONS  

Required: 

• High School Diploma with a minimum of 3 years in overall maintenance activities of which at least 1 years must be in a cGMP or other FDA regulated operation or a bio-tech facility is required. 
• Knowledge of maintenance procedures and techniques related to manufacturing and utility systems, that may include Autoclaves, CIP/SIP systems, Incubators, Analytical equipment, and Process tanks as well as other facility equipment. 
• Developing analytical and problem solving skills and experience applying these skills to resolve technical problems. 
• Good skills and experience in MS Office products (Word, Excel, Outlook, PowerPoint). 
• Knowledge of common documentation practices in GMP or cGMP manufacturing. 

 

Preferred: 

• Computer literate in a CMMS (Computerized Maintenance Management Software) such as Blue Mountain or similar computer based maintenance program desirable. 

 

Physical Requirements (US Only): 

• Ability to work in prolonged sitting, standing, walking, bend