Maintenance Technician, Senior at AGC Biologics

Bothell, Washington, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceuticals, BiotechnologyIndustries

Requirements

High School Diploma with a minimum of 10 years in maintenance, including at least 7 years in a cGMP or FDA-regulated biotech, pharmaceutical, or medical device facility
Experience with start-up and commissioning of cGMP facilities
Strong knowledge of maintenance procedures for manufacturing and utility systems (autoclaves, CIP/SIP systems, incubators, analytical equipment, process tanks, etc.)
Proficiency in troubleshooting using engineering drawings, P&IDs, and electrical schematics
Knowledge of electrical, mechanical, SCADA/PLC systems, process improvement methodologies, and root cause analysis
Strong analytical and problem-solving skills with experience applying them to technical issues
Proficiency with Microsoft Office (Word, Excel, Outlook, PowerPoint)
In-depth knowledge of documentation requirements for cGMP manufacturing
Strong written, verbal, and interpersonal communication skills
Demonstrated customer focus and professionalism
Ability to work independently and efficiently in a fast-paced environment
Preferred
Experience with CMMS software (Blue Mountain or similar)

Responsibilities

Perform preventative maintenance on manufacturing equipment such as bioreactors, pumps, valves, RO/DI water systems, steam generation, compressed air systems, and other manufacturing and utility systems
Troubleshoot, install, and repair complex instrumentation across production, laboratory, and facility systems, ensuring proper calibration to specifications and SOPs
Maintain a safe work environment, following all safety SOPs and PPE requirements
Maintain assigned facility areas to support inspection readiness and operational excellence
Complete maintenance work orders, engineering change controls, and related documentation in compliance with cGMPs using the site CMMS and Document Management Systems
Assist equipment owners in determining appropriate maintenance requirements through evaluation of specifications
Support internal and regulatory audits/inspections
Contribute to qualification activities, process improvement projects, and vendor coordination for maintenance services
Assist in the review and development of departmental SOPs and quality event investigations
Provide training, coaching, and technical direction to junior maintenance technicians

Skills

cGMP

preventive maintenance

bioreactors

pumps

valves

RO/DI water systems

steam generation

compressed air systems

instrumentation

calibration

troubleshooting

CMMS

SOPs

audits

PPE

AGC Biologics

Contract development and manufacturing for biopharmaceuticals

About AGC Biologics

AGC Biologics specializes in the development and manufacturing of therapeutic proteins, plasmid DNA, viral vectors, and genetically engineered cells for the biopharmaceutical industry. The company provides end-to-end solutions, assisting clients from the initial development stages to full-scale production. Their services are particularly focused on fast-tracking projects for orphan drugs and rare diseases, which often require quicker timelines. AGC Biologics operates a network of advanced facilities across the U.S., Europe, and Asia, all adhering to strict quality regulations known as current Good Manufacturing Practices (cGMP). What sets AGC Biologics apart from competitors is its commitment to continuous innovation and its recent expansion to enhance capabilities in cell and gene therapy. The company's goal is to support biopharmaceutical companies in bringing new treatments to market efficiently and effectively.

Bothell, WashingtonHeadquarters

2001Year Founded

$613MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Risks

Restructuring and layoffs in Colorado indicate potential financial instability.

Leadership changes may disrupt ongoing projects and affect client trust.

Significant investment in Japan could strain financial resources and divert focus.

Differentiation

AGC Biologics specializes in therapeutic proteins, plasmid DNA, and viral vectors.

The company offers fast-track project capabilities for orphan drugs and rare diseases.

AGC Biologics operates globally with facilities in the U.S., Europe, and Asia.

Upsides

Increased demand for plasmid DNA boosts AGC's gene therapy and vaccine services.

Partnership with BioConnection enhances biodrug development capabilities, attracting more clients.

Expansion in Yokohama aligns with growing mRNA and cell therapy demand.

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