Seagen
Quality Control Equipment Specialist - Launchpad
Technical Operations & Process Sciences - 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:
Seagen’s new cGMP manufacturing facility “project Launchpad” is being built in Everett, Washington, just North of Seattle. Launchpad will be a greenfield build encompassing end-to-end manufacturing capabilities for biologics and antibody-drug conjugates (ADCs).
This position will support purchasing, onboarding, and qualification of new QC equipment in support of the new manufacturing facility. This position also supports daily equipment management operations to ensure equipment are available for Quality Control (QC) to use for testing and ensure equipment are maintained in accordance with standard operating procedures (SOPs) in a cGMP compliant QC laboratory.
This position is dedicated to one QC site but may provide backup to other QC sites.
Principal Responsibilities:
- Ensure equipment is managed in accordance with governing procedures.
- Create new and review completed equipment records and tasks in the CMMS (computerized maintenance management system) as the System Owner.
- Take lead role and launch change control records for document and/or equipment changes.
- Address equipment alarms such as for temperature excursions including moving material to alternate storage unit, performing investigations into the cause for the excursion and assessing impact of the temperature excursion.
- Arrange purchase and receipt of new equipment.
- Perform data integrity and impact assessments for equipment and associated software.
- Perform periodic reviews of equipment and software as the System Owner.
- Perform equipment logbook reviews
- Coordinate with Facilities for scheduling calibration, maintenance, and repairs
- Support equipment software updates and upgrades by writing/revising, executing, and reviewing software validation test scripts as needed
- Support other equipment System Owners as needed
- A few hours of evening, weekend, and/or on-call work may be occasionally required to address equipment alarms
- May administer training system for a QC site including but not limited to user access, organizing training assignments, providing customer support for questions
- Apply the principles of good manufacturing practices (GMP) on a daily basis
- Create and revise standard operating procedures (SOP’s) and other documents as needed
- Identify and lead continuous improvement projects
- Maintain training to current standards and procedures on all assigned curriculums
- Fully comply with company health and safety procedures and practices
- Author and own deviations and CAPAs
Train and mentor other personnel
- Represent QC in cross-functional project teams
- Participate in regulating agency inspections, internal audits, and partner audits. May participate as subject matter expert (SME)
Required Qualifications:
- 8+ years relevant experience
- Bachelor’s degree or associates degree and 2+ years in relevant field
- Be highly organized with an attention to detail
- Ability to keep order of multiple projects/tasks
- Experience with Blue Mountain, Maximo, or other equipment maintenance management system
- Experience using or managing analytical lab equipment (pH meters, balances, HPLCs/UPLCs, etc.)
Preferred Qualifications:
- GMP experience
- Experience with software validation
- Familiarity with analytical instrument software such as Empower, 32 Karat, UV-Vis ChemStation, SoftMax Pro, iCE CFR
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 $94,000 to $121,000 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.
Apply:
Seagen
Seagen is an Equal Opportunity Employer
Submitted: 03/11/2023
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