Facilities Maintenance Technician, Senior

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.   

SUMMARY:

The Facilities Maintenance Technician. Senior is responsible for performing advanced level installations, maintenance, repairs and support of the facilities and utility systems PM Program at AGC Biologics. This is a key position that ensures the safety and reliability AGC Bio-Manufacturing Facilities are compliant and properly maintained. 

PRINCIPAL RESPONSIBILITIES:

• Perform preventative maintenance work on complex plant utility equipment such as high-pressure steam boilers, Heating, Ventilation, and Air Conditioning (HVAC) systems, pumps, valves, compressed air, waste water and other manufacturing and utility system equipment.
• Perform troubleshooting, installations and repairs of complex instrumentation on plant, laboratory and facility systems, ensuring all systems and devices are operating 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 operations.
• Complete maintenance work orders and engineering change controls and/or disruption work 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 to determine the appropriate maintenance information for their processes through the evaluation of equipment specifications.
• Assist in Regulatory and Internal Audits/Safety Inspections.
• Assist with Vendors to get maintenance quotes, etc., and Interface with maintenance contractors, ensuring work is compliant with AGC SOP's and safety requirements within the facility.
• Assist in the review and development of Maintenance Department Procedures.
• Assist in the development of investigations and initiation of any documentation resulting from Quality Events with respect to equipment.
• Provide leadership, training, coaching and technical direction to lower level Maintenance Technicians.
• Ensure compliance with all applicable regulatory agencies including FDA, OSHA, CFR, etc.
• May be required to participate in the on-call duties.
• May be required to receive alarm escalations and respond accordingly after-hours.
• All other duties as assigned.

KNOWLEDGE, SKILLS & ABILITIES:

• Strong leadership skills and knowledge of maintenance procedures and techniques related to facility and utility systems such as: Emergency generators, Fire systems, steam/hot water boilers, vacuum pumps, Process tanks, laboratory equipment/systems, as well as facility construction/civil work.
• Strong written, verbal and interpersonal communications skills.
• Strong analytical and problem solving skills and experience applying these skills to resolve technical problems.
• Strong skills and experience in MS Office products (Word, Excel, Outlook, PowerPoint).
• Computer literate in a CMMS (Computerized Maintenance Management Software) such as Blue Mountain or similar computer based maintenance program desirable.
• Demonstrated ability to works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine recommendations to management
• Knowledgeable of Electrical, Mechanical, Control/SCADA, PLCs, Process Improv