Seagen

Senior GMP Equipment Specialist

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!

Seagen is seeking a Sr. GMP Equipment Specialist to act as the principal contact and liaison between facilities, production, quality, safety, and other supporting departments in relation to determining scope, timing, and execution of planned life-cycle activities for GxP laboratory systems and assets, including freezers, refrigerators, incubators, hoods, liquid handlers, RO water purification units, centrifuges, HPLC/UPLCs, etc.

The Sr. GMP Equipment Specialist will be accountable to utilize their skills and experience to achieve the safe and accurate completion of tasks at their assigned location with minimal supervision. This position is responsible for performing advanced calibrations, maintenance, repairs, installations, troubleshooting and documentation of instruments used on process control systems, analytical labs and utility building systems for manufacturing and testing.

The Sr. GMP Equipment Specialist is expected to work to maintain equipment in a qualified state of control by following site SOP’s and the Change Management process. This position will work with cross functional departments on improvement initiatives, Deviation Investigations and CAPA. This role reports to the Supervisor, Scientific Services Management.

Principal Responsibilities:

• Timely completion of tasks and work orders with appropriate documentation according to standard operating procedures, applicable standards, guidelines, practices, and policies.  Maximize “wrench time” of technicians and business partners by ensuring necessary equipment, parts, tools, plans, and procedures are provided in advance.
• Scheduling and coordinating activities focused on the installation, modification, relocation, and decommissioning/retirement of laboratory assets with minimal interruption to facilities and laboratory operations where time efficiencies, resources, and good customer services are competing objectives.
• Investigate related issues, analyze root causes, and drive solutions.
• Lead and train crafts persons in skills necessary to become proficient.
• Lead projects and meetings.
• Coordinate various equipment OEM and vendor activities.
• Conduct training, communications, and escort of equipment contractors, OEM and vendors.
• Lead incident and deviation investigations.
• Assure compliance with safety, quality, and environmental requirements.
• Manage related aspects of the CMMS/EAM and other work ticketing systems.
• Manage related work backlog.  Author and revise facility SOPs.
• Safe operation of tools and shop equipment, housekeeping and safe execution of work in the field.
• Demonstrated proficiency to monitor, trend and analyze data to make corrections or recommendations.
• Lead systems start-up, new installations.
• Assistance with identification, purchase, and organization of spare parts.
• Initiate and champion instrument or equipment related Change Requests (CR).
• Site technical Authority  Support site audits.
• Maintain Remote Monitoring equipment.
• Participate in On-Call rotations and available for after-hours facility and manufacturing support and work outside of established shift hours upon short notice such, as evenings and weekends.

Qualifications:

• At least five (5) years of experience in a cGMP biopharmaceutical environment (i.e. - laboratory, Clinical Manufacturing, or Commercial Manufacturing).
• Must have a minimum of two (2) years Facilities Maintenance Planner/Scheduler experience in a cGMP biopharmaceutical environment.
• Intermediate knowledge of CMMS/EAM use, administration, and management. BMRAM experience highly preferred.
• Computer skills are a must with intermediate to advanced knowledge of MS Office suite and other data and information management systems, including change management and document control.
• Parts and materials inventory management experience.

Education

• High School Diploma or GED with related technical certification(s) or, 4-year degree in biotechnology related field.

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 $90,000 to $117,000 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: 01/07/2023