Description

Position at Seagen 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: Seagen is seeking a Sr. Reliability Engineer within the Engineering Center of Excellence, COE within RE & Facilities (REF). In this engineering function, the role will have the responsibility for developing and maintaining a reliability program which assures the facility equipment and systems are operated and maintained to achieve 100% uptime. The reliability program will include developing a predictive maintenance program. The reliability program will be based system performance data that will be reviewed and analyzed as a basis of decision making for optimization of the facilities systems and equipment. The function will support to assure that new equipment and systems achieve 100% reliability. This role will report to the Global Director of Engineering Services, Center of Excellence. This person will possess strong engineering acumen and understanding of equipment operations and maintenance. This role will be accountable for maintaining reliability engineering expertise and competency across sites. The expectation is this function will set a target for Best-in-Class results while focusing on quality product for Seagen patients. Principal Responsibilities: The Reliability Engineer must exhibit a keen interest in data and numbers, often collecting and analyzing key data metrics from processes or components. This role requires the ability to create statistical analysis, charts, drawings, and reports to help illustrate and showcase potential issues within the facility and equipment. This data will be used to improve the infrastructure reliability. Many issues involve taking a macro look at other factors and determining how these factors could impact the infrastructure reliability. Daily responsibilities include but are not limited to the following: Identifying and reporting on potential failures within a process

Assisting with the design of new systems

Applying general engineering knowledge to solve problems

Performing tests and analysis that includes:

Failure mode and effects analysis (FMEA) Reliability hazard analysis Dynamic reliability block-diagram analysis Fault tree analysis Accelerated testing Avoidance of single point of failure (SPOF) Functional Hazard Analysis (FHA) and functional failure analysis (FFA) Testability analysis Human error analysis Operational hazard analysis

Check new systems or installations

Work closely with budgets and finances to help reduce costs

Conduct routine engineering calculations

Liaise with relevant teams on outcomes of tests/analysis

Produce technical drawings and schematics

Analyze system performance data trends and present this data using Power BI dashboards to present the results of this data for review by all levels of management

Drive Root Cause Analysis and ensure close out of CAPAs and action items

Supports the REF Recapitalization and Facility Master Plan programs

Maintain all building equipment, facilities, and utilities in an effective operational and compliant state

Ensure that installations and changes to equipment and systems are carried out, commissioned (validated and qualified if applicable), and documented according to approved protocols, change control procedures and in compliance with relevant cGMP and corporate requirements

Build a site Infrastructure Master Plan (5 years) that provides a roadmap for required facility upgrades and investments to ensure alignment with Quality & EHS requirements

Provide guidance to ensure compliance with all applicable external and internal regulations and requirements regarding Quality and EHS within the scope of Engineering

Drive Continuous Improvement to meet/exceed world-class engineering standards using Operational Excellence principles while continuously developing Engineering best practices

Establish and manage risk management and escalation process to ensure proactive measures are taken to reduce impact or risk to Seagen - EHS, Quality, Compliance, Security, Operations, Facilities, or REF

Identify and support innovations by implementing new technologies which drive growth and process improvements using digital data and analytics (DD&A) such as Power BI

Provide reliability engineering for maintenance and facilities by collecting and analyzing equipment performance data, develop and implement preventive and predictive maintenance programs, reliability centered maintenance program, run to failure

Develop and implement continuous improvement systems for maintenance and facilities, targeting asset maintenance cost. Utilize reliability processes like FMECA’s to ensure robust maintenance programs

Influence senior management in decision making

Gain understanding and work with others to optimize the CMMS (EAM) system usage at the site

Predictive Maintenance Optimization (PMO)

Manual screening

Required Qualifications: Mechanical, Chemical, Industrial, or Electrical Engineer

Minimum 10 years-experience and progressive experience within GxP environment – pharmaceutical, biotechnology or biologic industry

Proficient use of Maximo or similar Computer Maintenance Management System (CMMS)

Experience with developing and maintaining a predictive maintenance program

Understanding of aspects for Commissioning, Qualification, and Validation activities

Ability to work across functional groups

Preferred Qualifications: 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

Additional accreditations or certification especially centered around reliability and predictive maintenance

Professional Licensed/Registered Mechanical, Chemical, or Electrical Engineering in Washington

The hiring pay range for this position is $123,000 to $160,000 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 and an annual bonus.