Seagen
Commissioning & Qualification Senior Engineer - Launchpad
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:
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).
The Commissioning and Qualification Sr. Engineer, is responsible for leading and performing equipment validation projects for Seagen, Inc. This position supports equipment qualification for utilities by coordinating GxP equipment enrollment & commissioning, developing, reviewing, and approving equipment qualification protocols and reports. Responsible for creating, updating, and maintaining Facilities qualification SOPs and work instructions. The Sr. C&Q Engineer will provide technical, commissioning and qualification guidance as subject matter expert (SME) relating to Utilities, Facilities, change control and Operational technology implementation projects.
This position reports to the Sr. Mgr. C&Q.
Principal Responsibilities:
- Proven track record of Audit Preparation and Readiness with Quality, Compliance and Safety
- Proven knowledge of applying Risk Based Approach for C&Q activities within the biotechnology industry
- Accountable for C&Q activities supporting the site Facility and Utility equipment
- Using Good Engineering practice, enroll and commission equipment for qualification
- Plan and execute complex equipment/utility IQPQs
- Champion CRs and coordinating with QA and Facilities GMP technicians
- Conduct equipment validation training, communication, and escort of equipment validation contractors
- Support validation exception investigations
- Champion equipment validation Continuous improvement efforts
- Revising and maintaining equipment validation procedures
- Ensures Good Documentation and Good Engineering Practices, GDP and GEP
- Leads, develops, executes, and documents validation programs for facilities/utilities and equipment (both internally and for externally manufactured products)
- Responsible to review technical requirement specifications and project documentation supporting C&Q protocols such as URS, FS, P&IDs, Isometrics, FAT, SAT, Installation and Operation Commissioning tests, IQ and OQs
- Ensures adherence and compliance to pre-start up safety checks, LOTO and site safety programs
- Functional area participant to support C&Q deliverables such as system impact assessments, establishing system boundary drawings, traceability matrix
- Manage oversight of 3rd party organizations with inspections, document redline, review of C&Q supporting documentation
- Participate in change controls, deviations, investigations, corrective/preventive actions, root cause analysis to drive timely close out
- Supports other groups validation and qualification exercises
Required Qualifications:
- University degree and a minimum of 3 years of related experience
- Introductory and annual refresher GMP Training
- Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
- Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results
- Networks with key contacts outside own area of expertise
- Determines methods and procedures on new assignments and may coordinate activities of other personnel (Team Lead)
- Passion for Continuous Improvement (CI)
- Effective team player and strong communicator
- Ability to self-start and direct activities in the absence of supervision
Preferred Qualifications:
- Engineering degree and a minimum of 5 years of related experience
- American Society of Quality Certification or equivalent
- ERAPS Certification
- EGMP Certification
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 $107,000 to $138,600 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.
The hiring pay range for this position is $107,000 to $138,600 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.
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: 01/27/2023
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