The Maintenance Technician is responsible for executing, maintaining and improving the cGMP equipment PM Program at client facilities in Bothell, WA. 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.
- 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.
- All other duties as assigned.
KNOWLEDGE, SKILLS & ABILITIES:
- 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.
- Good written, verbal and interpersonal communications skills.
- 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).
- Computer literate in a CMMS (Computerized Maintenance Management Software) such as Blue Mountain or similar computer based maintenance program desirable.
- Knowledge of common documentation practices in GMP or cGMP manufacturing.
- 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.
- Ability to work in prolonged sitting, standing, walking, bending, stooping and stretching.
- Ability to climb ladders and stairs of various heights.
- Ability to be exposed to wet or humid conditions.
- Ability to be exposed to outdoor weather conditions.
- Ability to be exposed to noisy environments.
- Ability to regularly lift and/or move up to 45 pounds and occasionally lift and/or move up to 70 pounds briefly.
EDUCATION / EXPERIENCE:
- 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