Seagen

Manufacturing Lead Facility Cleaning

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!

Position Summary:

The successful candidate will oversee a team of contract GMP facility cleaners to ensure compliance with procedures established for the North Creek Manufacturing Facility GMP manufacturing areas. This position will partner with internal Manufacturing, Quality, and EH&S groups to ensure contract cleaners execute cleaning as expected and to drive overall improvement of the GMP cleaning program. The successful candidate will be the subject matter expert for GMP facility cleaning and will ensure that the facility cleaning program is inspection ready.

Principal Responsibilities:

• Ensure cleaning personnel, internal and contract, are properly trained for facility GMP cleaning.
• Perform hands on-training for facility cleaners as required.
• Oversee the execution of facility cleaning by contract cleaning staff to ensure compliance with cleaning procedures.
• Review facility cleaning logbooks and records for compliance and errors. Initiate corrections as required.
• Participate in investigations involving compliance events
• Participate in the North Creek continuous improvement program. Drive continuous improvement initiatives related to GMP facility cleaning; strive to reduce human errors.
• Conduct routine inspection of the facility for cleanliness. Correct any deficiency as required to ensure facility is suitable for the manufacture.
• Communicate with Manufacturing and Quality stakeholders to ensure proper cleaning protocol is applied as the situation requires.
• Plan and coordinate cleaning schedule with the operations in the facility and ensure all types of cleanings are executed per the frequency as dictated by the procedure.
• Partner with Environmental, Health, & Safety department to ensure facility cleaning is safe for cleaning crew and other personnel in the manufacturing areas.
• When necessary, participate in hands-on facility cleaning.
• Liaise with contractor management company and provide feedback on technician performance.
• Ensure cleaning supplies closets/cabinets are organized and inspection ready.
• Develop and track key performance indicators (KPI) for GMP facility cleaning program.
• Develop training content and materials to support the GMP cleaning program.
• Creates, revises, and reviews SOPs (standard operating procedures).
• Leads investigations of safety or quality issues, as necessary. Authors investigations for deviations related to processing operations ensuring timely and complete documentation.
• Perform support activities as needed for the overall efficiency of the manufacturing operations.
• Successfully represents the group regarding manufacturing support operations and associated equipment/procedures during audits/inspections or at cross functional team meetings.

Required Qualifications:

• 2 - 5 years of GMP biopharmaceutical industry and/or GMP facility cleaning experience
• 1 - 2 years of supervisory experience
• Demonstrated ability and experience working with cross-functional teams
• Demonstrated ability to influence and engage indirect reports and peers
• Knowledge of applicable business systems including: MRP, EAM, and QMS desired
• Excellent organizational and planning skills required
• Strong verbal and written communication skills and interpersonal skills
• Proficient in Microsoft Office suite
• Able to work equally well as part of a team or independently
• Ability to lift 20 kg and stand for extended period-of-time
• This position requires shift work hours from late afternoon to evenings (approximately 2 pm to 10 pm) and will require work on weekends as necessary

Preferred Qualifications:

• Bachelor’s degree in life science preferred. Associate’s or high school degree is acceptable with commensurate relevant work experience

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 $80,000 - $103,400 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: 01/13/2023