Seagen

Lead Instrument Technician

Corporate Functions - Bothell, United States

Description

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary:

The Lead Calibration Technician is responsible for the on-time execution of calibration activities while adhering to GxP guidelines and defined SOP’s. The Lead is proficient in the calibration of temperature, pressure, flow, weight, level, speed, gas analyzing, pH, conductivity, and electronic instruments. A self-starter who works unsupervised, leads lower-level team members, and maintains a high attention to detail. The Lead is a metrology subject matter expert and serves as an advisor to the Supervisor.

Principal Responsibilities:

• Perform calibration work on complex instruments such as temperature, pressure, electronic, flow, weight, level, speed, pH, conductivity, laboratory equipment, and other manufacturing and process utility system instrumentation
• Perform troubleshooting, installations, and repairs of complex instrumentation on production, laboratory, and facility/utility/equipment systems ensuring all systems and devices are calibrated in accordance with manufacturer's specifications and Seagen internal SOP’s
• Create, develop, and update instrument job plans (JPs). Establish, maximize, and improve calibration process tolerances for site instrumentation while maintaining data integrity and measurement traceability for the Calibration Program
• Maintain assigned area of ownership within the facility to support inspection readiness and general facility upkeep in support of clinical and commercial manufacturing
• Complete calibration work orders, Corrective Actions/Preventative Actions (CAPA’s) and change controls within the allotted time
• Maintain all calibration records, work orders, and investigations in an orderly and accurate manner in compliance with cGMP’s by the utilization of the site Enterprise Asset Management System (EAMS) and Document Management Systems
• Collaborate with Manufacturing, Quality, and Materials Management to understand issues, opportunities for improvements, and partner with them to drive optimization of programs
• Assist in qualification activities related to instrumentation and process improvement projects
• Assist with off-site calibration activities, communicating with vendors to get calibration quotes and purchase orders etc., and interface with calibration contractors ensuring work is compliant with SOP's and cGMP's within the facility
• Assist in the development of investigations and initiation of any documentation resulting from 'Out of Tolerance' conditions with respect to instrumentation
• Provide training, coaching, and technical direction to lower-level Calibration Technicians
• Ensure compliance with all applicable regulatory agencies including FDA, OSHA, CFR, etc.
• Plan sequence of testing and calibration procedures for instruments and equipment
• Assist in Regulatory and Internal Audits inspections
• Demonstrate continuous personal pursuit to increasing job knowledge and proficiency with different systems
• Maintain a positive, professional, and customer-oriented attitude
• May be required to participate in after hour On-Call support
• All other duties, as assigned

Required Qualifications:

• Associate degree or completion of an Instrumentation or Industrial Electronics (2-year) curriculum at a technical school with 5+ years of work experience
• Minimum of 8 years of overall experience in calibration activities of which at least 3 years should be in a cGMP or other FDA regulated operations

Preferred Qualifications:

• CCST Level 1 Certification
• Experience in an instrumentation role in a GMP manufacturing facility
• Knowledge of computerized instrumentation, microprocessor-controlled operations, and micro measurement equipment is beneficial
• Knowledge of bio-medical, bio-technical equipment, both upstream and downstream desirable

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

The hiring pay range for this position is $65,000 to $84,700 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/20/2023