GxP Hard Services & Calibration Manager - Bothell, WA

Employer: Seagen Inc.

Job 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 is seeking a GxP Hard Services & Calibration Manager, within the Real Estate & Facilities (REF) organization. This management role is responsible for site Maintenance, Calibration, and associated contract services. This includes providing leadership and direction in the development of the daily operational strategy, policy, and standards for optimizing the delivery of all aspects of GxP maintenance and lab services across the R&D and Manufacturing businesses. This role will work closely with the key stakeholders to drive high-quality service performance and identify opportunities to optimize cost through efficient workplace integration and implementation. They will lead and manage a team of highly skilled, diverse SMEs in their day-to-day activities to apply innovative thinking to performance challenges across manufacturing services. This includes building the team, embedding best practice processes, managing key customer relationships, and planning efficient resource allocation across the team. This role will report to the Sr. Director of Global Facilities Management.

Principal Responsibilities:

Responsible for overseeing the maintenance and instrumentation, including equipment, lab, and facility maintenance, testing, troubleshooting, calibration, and repair of all buildings and equipment at the site
Lead and direct daily operational management of planning/scheduling, maintenance, and calibration activities, while ensuring alignment with Corporate EHS, Quality, and Compliance for site operations support
Maintain all building equipment, facilities, and utilities in an effective operational, and compliant state
Use Quality Management Systems, QMS, to manage department Change Control, Deviation, and CAPA records
Work with the site leadership management teams, to develop and implement long-range facilities plan to reach objectives and ensure that tactical facilities decisions are consistent with this plan
Collaborate with FM organization leaders and site maintenance, and calibration leadership to build a DAI model for separate accountability and responsibility focuses for engineers, maintenance technicians & facilities technicians
Proactively manage relationships with customers, internal and external work partners, and leaders across the matrix organization
Contribute to the workstream for establishing and managing risk management and the escalation process to ensure proactive measures are taken to reduce impact or risk to Seagen - EHS, Quality, Compliance, Security, Operations, Facilities, or REF
Serve as the main Seagen representative in communication with suppliers, subcontractors, and planning firms regarding the site’s assets, equipment, systems, and maintenance services
Works closely with Quality Assurance to develop maintenance SOPs and protocols to comply with regulatory requirements
Evaluates current PM cycles and make appropriate recommendations to optimize the Maintenance Program
Contributor to site Risk Assessments and Root Cause Analysis
Monitors and validates performance reporting to ensure appropriate metrics are delivered by the service providers to key internal stakeholders
Manages GxP service compliance adherence and identifies/escalates service risks to appropriate leadership
Proactively seeking cost-effective approach without compromising the quality of service, working all aspects of the P&L to deliver viable business propositions
Organized and driven approach to managing projects, GxP team members, etc. to establish and deliver on key initiatives and performance targets
Mentors, teaches, and coaches GxP team members and service partner leadership on maintenance and calibration service excellence principles, best practices, techniques, and behaviors
Lead a culture of innovation, continuous improvement, and customer focus.
Ensures adherence to Seagen Data Integrity principles
Ensures compliance against local, state, federal, country, and industry requirements.
SME and point of contact for planning, scheduling of maintenance, and shutdown activities
Ensures accountability for site Safety Culture

Qualifications:
7+ years of progressive experience with 3+ in management of technical staff within GxP environment – pharmaceutical, biotechnology or biologic industry
Proven technical expertise in GxP instrument, maintenance, and CMMS
Demonstrated knowledge and understanding of GxP standards & requirements
Advanced knowledge of GxP production systems and equipment, automation systems and controls, power generation and UPS systems, fire alarm, and sprinkler systems
Advanced knowledge of process waste treatment systems, plant water and steam chemical treatment, WFI, PW, DI water, and clean steam production and distribution systems
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, and excellent reading, and computer skills
Knowledge of word processing, electronic spreadsheets, and database software programs (CMMS/EAM experience)

Education:
2 years technical or AA/AS degree in facilities maintenance, mechanical, or related technical discipline, engineering degree, or equivalent combined education and experience

Preferred Requirements:
Experience using Computer Maintenance Management Systems, CMMS
Ability to build effective cross-functional / department teams and drive decision making
Customer-centric and able to demonstrate customer relationship management
Outstanding managerial skills and leadership in a demanding and rapidly evolving environment
Excellent interpersonal and presentational skills to successfully interact with managers at all levels
Acts as a role model for applying standards to ensure compliance
Ability to lift a maximum of 50 lbs
Willingness to work off hours to complete maintenance assignments, on-call duty

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.

Please apply by clicking on this link https://www.seagen.com/careers/explore-jobs?p=job%2Foi5Hlfw9

Contact Person: Simone Leblon
Phone:
Email: sleblon@seagen.com
Location: Bothell, WA
Application Method: apply online https://www.seagen.com/careers/explore-jobs?p=job%2Foi5Hlfw9
Base Pay:

Posted on December 12, 2022

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