Seagen

Manager GxP Calibration, Maintenance & Hard Services

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 is seeking a GxP Hard Services & Calibration Manager Calibration, Maintenance & Hard Services 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:

• Teach and coach internal team members and service partner leadership on service excellence principles, techniques, and behaviors
• Provide guidance, support, and goals for service teams responsible for delivering services to sites / region
• Embed a culture of innovation, continuous improvement, and customer focus. Create strong teamwork between REF, its service partners, and its customers.
• Oversee 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 a 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
• 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
• Track record of effective team building and coaching
• 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)

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

Education:

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

The hiring pay range for this position is $116,000 to $149,600 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: 12/23/2022