GMP Supervisor, Soft Services

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 is seeking a contract Facilities Supervisor for the North Creek cGMP Manufacturing Facility. The Facilities Supervisor is responsible for soft services including Janitorial, Garbage/Waste Removal, Pest Control, Landscaping, and site needs. These services must be performed in compliance with cGMP and EHS SOP’s standards and directives. The supervisor will drive results to support plant strategic initiatives and will coach/mentor employees and contractors to drive performance. Must have the ability to manage multiple priorities in a dynamic manufacturing plant setting, prioritizing individual, and team responsibilities accordingly.

The expectation is this function will set a target for Best-in-Class results while focusing on quality product for Seagen patients. 

Responsibilities:  

• Supervise the Janitorial, Garbage/Waste Removal, Pest Control and Landscaping maintenance services and ensure programs are in alignment with company policies and procedures 
• Strong ability to manage requests and help the needs of the North Creek site, which includes asset and site maintenance 
• Responsible for managing soft service technicians, oversight includes tracking workload, labor hours, following up on outstanding repairs and addressing customer service needs 
• Ensure EHS and cGMP compliance targets are met including KPI’s and training 
• Develop and complete quality system GMP documentation such as Standard Operating Procedures (SOP), Work Orders (WO), work plans, etc. 
• All work must be completed in a safe timely manner according to planning and predefined schedules with minimal impact to production while complying with Good Manufacturing Practices (GMP), SOP, Code of Federal Regulations (CFR) and Seagen regulations 
• Ability to interact collaboratively with the Facilities Engineering department as well as Manufacturing and other internal/external customers 
• Strong organizational and time management skills 
• Proven record of building cross functional relationships in a dynamic and regulated environment 
• Inspect, monitor, assess and assure the facility remains GMP compliant and in a constant state of audit readiness 
• Forecast budgetary needs for North Creek soft services in alignment with strategic direction 
• Generate and revise/modify operational SOPs as required for new or existing Facilities services 
• Manage CAPA and Change Records as system owner 
• cGMP compliance audit SME for soft services 
• Implement industry standards and strategies in Facilities services 
• Compile data to provide performance metrics for management 
• Supervisor monthly and quarterly partner reviews of service contract providers 
• Establish and manage SLA for soft services 
• Provide general expertise and training to junior staff in all areas of responsibility 
• Complete GMP and other controlled documentation in accordance with GMP/FDA requirements 
• Drive performance and accountability with team members by providing a positive and equitable work environment emphasizing respect, responsiveness, and results 
• Assure Work Orders and PMs are performed in an efficient manner and reported as required in Maximo 
• Coordinate, oversee and manage contractors as needed to meet the responsibilities and commitments of the Facilities department 
• Perform disposal of Hazardous Waste as required in accordance with local and federal regulations 

Qualifications:  

• BS degree or equivalent in a relevant discipline  
• 4 years of relevant experience or equivalent combination of education  
• 4 years combined education and experience in building maintenance and Facilities Management 
• Experience in an FDA regulated environment (GMP) 
• Experience supervising soft services including Janitorial, Pest Control, and Landscaping in a GMP regulated environment 
• Effectively communicates ideas through verbal and written forms, interacts constructively with peers/teams, and can seek outside resources as needed 
• Possess a high mathematical understanding, advanced reading, writing and computer skills 
• Knowledge of word processing, electronic spread sheets, and database software programs (CMMS/EAM experience)  
• Advanced technical writing skills 
• Advanced knowledge and experience of regulatory requirements of ISO and GMP 
• Self-motivated 

Preferred Qualifications:  

• Experience preferably in a GMP biopharmaceutical, pharmaceutical, food or other batch processing industries 
• Experience use of Computer Maintenance Management Systems, CMMS 
• Ability to influence and persuade cross functional groups  
• In-depth knowledge of FDA, EMA, GxP and ICH regulatory requirements 
• Proficient use in MS Office as well as discipline-specific and project management software applications 
• Ability to build effective cross functional / department teams and drive decision making 
• International Professional 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.  

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. 

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