Seagen
Facilities Engineering Maintenance Supervisor
Corporate Functions - Bothell, Washington
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
The Maintenance Supervisor at the North Creek Manufacturing Facility is a skilled, diverse craftsperson responsible for supervising and performing advanced installation, troubleshooting, maintenance, repair, testing, and associated documentation of a wide variety of manufacturing production equipment, lab equipment and process utilities. This technician will also provide maintenance and support to general building and utility systems including electrical infrastructure and life/safety systems.
This role will support the Facilities Engineering manager by leading the team of Maintenance Technicians, executing critical maintenance and utility operations, supervising employees by giving direct and detailed assignments and reviewing the results.
North Creek is a cGMP Commercial biologics manufacturing facility. All work must be completed with minimal impact to production while complying with cGMP regulations, when appropriate, and Seagen regulations.
Principal Responsibilities:
- Serve as the Lead for the site mechanical technicians for facilities and utilities systems
- Applies SME and technical knowledge to support data driven decisions
- Drives the development of staff within a cGMP environment
- Active Lead or contributor for system Trouble shooting
- Supervise and perform advanced installation, maintenance, troubleshooting, repair, and testing, of a wide variety of office, utility, lab, and facility equipment
- Works closely with Quality Assurance to develop maintenance SOPs and protocols to comply with regulatory requirements
- Evaluates current PM cycles and makes appropriate recommendations to optimize the Maintenance Program
- Use internal quality systems to generate, assess, and close Change Control, Deviation, and CAPA records
- Applies Good Documentation and Data Integrity principles in daily work operations
- Adheres to site EHS, Quality and Compliance site operation procedures
Contributor to site Risk Assessments and Root Cause Analysis
- Collaborates with various functions including Site operations, QA, QC, EHS, Compliance, Reliability Engineering, PMO
- Applies working knowledge of including but not limited to Permit to Work, Stop Work, Job Hazard Analysis
- Operates, logs, and maintains building and utility systems in accordance with standard Operating Procedures
- Work performed must be completed and documented/logged in accordance with written SOP's and GMP guidelines, when applicable
- Plans and schedules own, and others work activities with operations staff
- Assigns work orders in the CMMS system to technicians
- Reviews and technically approves maintenance reports, forms, and records
- Develops, revises, and reviews equipment, maintenance, or other related procedures
- Lead/supervise small projects
Participate in the capital planning process
- Maintain all documentation pertaining to maintenance and repair of equipment
- Prepares, plans, and performs building and laboratory equipment moves and installations
- Leads the start-up of new equipment to ensure it meets all mechanical design specifications
- Maintains, interprets, and updates electrical schematics, P&IDs, panel/building drawings, and equipment/building O&M manuals
- Assists with the preparation and execution of commissioning and validation protocols
- Develops and provides detailed training for the team to develop the team's knowledge in the maintenance field and other areas of the plant
- Maintain personal training records and takes charge of own training and ongoing education
- May be required to work in clean rooms and restricted environments using specific procedures
- May perform general labor duties as needed
- May be required to work outside of core business hours upon short notice
- May be required to work in awkward locations and lift items in excess of 50 pounds
- Participates in On-Call rotation for after-hours facility support
Fully complies with all company health and safety procedures and practices
Other duties and responsibilities as assigned
Qualifications:
- 10+ years combined education and experience in building maintenance, including operation, troubleshooting and repair of utilities and process equipment used in a GMP manufacturing plant, typically with 6+ years in an FDA regulated environment (GMP)
- Advanced knowledge of GMP production systems and equipment, automation systems and controls, power generation and UPS systems, fire alarm and sprinkler systems
- Advanced knowledge of pneumatic, mechanical, and hydraulic fundamentals, electrical distribution systems, plant steam production and distribution systems
- Advanced knowledge of HVAC, refrigeration systems, compressed air and lab gas systems, use of power and hand tools
- Advanced knowledge of process waste treatment systems, plant water and steam chemical treatment, WFI, PW, DI water and clean steam production and distribution systems
- Advanced skills in the building trades such as carpentry, plumbing, and painting
- 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, excellent reading and computer skills
- Knowledge of word processing, electronic spread sheets, and database software programs (CMMS/EAM experience)
- Advanced technical writing skills
- Applies ISPE, FDA, EU regulatory requirements to daily standard work
- Knowledge of commissioning, qualification and validation concepts
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.
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.
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: 10/29/2021
|