Maintenance Technician IV
Company: AGC Biologics
Posted on: June 18, 2022
AGC Biologics is a leading global Contract Development and
Manufacturing Organization, with a deep commitment to improving
life quality by bringing new biopharmaceuticals to market. Because
of our dedication to building and empowering our internal teams,
AGC Biologics is an innovative leader in the industry with an
extensive network of cGMP facilities in the US, Europe and Asia. As
such, we deliver a deep expertise, dynamic solutions and
technologies, as well as customized services for the scale-up and
cGMP manufacturing of protein-based therapeutics and cell and gene
therapies. We forge exceptionally strong partnerships with our
clients, and we never lose sight of our pledge to deliver a
reliable and compliant drug substance supply, Right, On time. For
more information, visit www.agcbio.com.SummaryThe Maintenance
Technician IV is responsible for executing, maintaining and
improving the cGMP equipment PM Program at AGC Biologics 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
- Perform 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.
- Perform 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
- Maintain a safe work environment; work in a safe manner
following all safety SOP's and wear Personal Protective Equipment
- 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
- Assist Equipment Owners determine the appropriate maintenance
information for their processes through the evaluation of equipment
- Assist in qualification activities related to Instrumentation
and Process improvement projects.
- Assist with Vendors to get maintenance quotes, etc., 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
- Ensure compliance with all applicable regulatory agencies
including FDA, OSHA, CFR, etc.
- All other duties as assigned.Knowledge, Skills & Abilities
- Strong 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.
- Strong written, verbal and interpersonal communications
- 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
- Knowledgeable of Electrical, Mechanical, Control/SCADA, PLCs,
Process Improvement Methodologies, Root Cause Analysis (RCA),
Biotechnology, Pharmaceutical, Medical Device Utilities
- Knowledge of documentation requirements for cGMP
- Demonstrated good interpersonal skills, customer focus, and
- Ability to read, interpret, and troubleshoot engineering
drawings, P&IDs, and electrical schematics with assistance when
- Ability to work quickly and effectively without constant
- 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
- High School Diploma with a minimum of 7 years in overall
maintenance activities of which at least 3 years must be in a cGMP
or other FDA regulated operation or a bio-tech facility is
- Experience with Start-Up & Commissioning of cGMP
Facility.Compensation Range$37.54 - $45.04 per hourAGC Biologics
offers a highly competitive compensation package and a friendly,
collaborative culture that values personal initiative and
professional achievement. AGC Biologics is an equal opportunity
employer. All qualified applicants will receive consideration for
employment without regard to age, ancestry, color, family or
medical care leave, gender identity or expression, genetic
information, marital status, medical condition, national origin,
physical or mental disability, political affiliation, protected
veteran status, race, religion, sexual orientation, or any other
characteristic protected by applicable laws, regulations and
Keywords: AGC Biologics, Boulder , Maintenance Technician IV, Professions , Boulder, Colorado
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