Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The GMP Systems Specialist will primarily focus on the facilitation of routine calibration, maintenance and repairs of GMP manufacturing and laboratory equipment to ensure a continued state of regulatory compliance and continuity of clinical manufacturing operations.

Responsibilities

• Track, schedule and ensure on-time completion of routine equipment service events.
• Establish and manage service providers and vendor contracts related to equipment maintenance, calibration, and repair.
• Maintain pertinent documentation and equipment files, including drawings, O&M manuals, equipment logbooks and service records in accordance with GMP record keeping practices.
• Facilitate shipment of equipment that is serviced off-site.
• Escort vendors into the cleanroom as necessary for equipment service.
• Perform necessary maintenance on incubators per SOP.
• Defrost and clean cold storage units per SOP.
• Respond to notifications of malfunctioning equipment, facilitate investigation to diagnose cause, coordinate repairs by FHCC Engineering or other service provider, as necessary.
• Facilitate verification of restored performance following equipment repairs, to ensure equipment is suitable to return to service.
• Identify issues and deviations, work collaboratively with the team to problem solve and implement changes.
• Lead by example and take responsibility in the support of safety and cGMP compliance.
• Communicate with vendors and TPP management for maintenance event scheduling.
• Resolves and/or escalates issues to appropriate management in a timely fashion.
• Create a positive team environment that instills trust, acknowledge individual contributions, encourage team engagement.

GMP Systems Specialist II

In addition to the responsibilities above:

• Support development of equipment specifications (user requirements) for new equipment, participate in equipment selection, procurement, installation, etc.
• Facilitation of process equipment commissioning and qualification, routine calibration, maintenance, and repairs of GMP manufacturing and laboratory equipment to ensure a continued state of
• regulatory compliance and continuity in support of clinical operations.
• Respond to notifications of malfunctioning equipment, participating in investigation to diagnose cause, coordinate repairs by Fred Hutch Engineering or other service provider, as necessary.
• Author equipment validation protocols and reports.
• Assist in execution of validation protocols.
• Investigate and document validation deviations.
• Support development of operation and maintenance Standard Operating Procedures (SOP) for new equipment.
• Assist manufacturing staff with troubleshooting and/or continuous improvement of equipment operations.
• Provide additional support for GMP equipment life cycle, as needed.

Qualifications

GMP Systems Specialist IMinimum Requirements:

• Bachelor's degree or higher.
• A minimum of 2 years of GMP experience in cell therapy, biologics or pharmaceutical manufacturing or quality assurance.
• Technical writing skills.
• Advanced knowledge of GMP requirements and understanding of regulatory landscape
• Familiarity with handling temperature-sensitive products including receiving, storage, labeling and packaging.
• Self-motivated and detail-oriented with absolute adherence to all related procedures.
• Computer skills including work with database programs (Access), spreadsheet programs (Excel) and word processing (Word).
• Communicate, read, and write legibly in English.
• Ability to follow guidelines of the Standard Operating Procedures (SOPs) for each operation in the process to conform to the Good Manufacturing Practice (GMP) and the Food and Drug Administration (FDA) Regulations

GMP Systems Specialist IIMinimum Requirements:

• Bachelor's degree or higher.
• A minimum of 4 years of GMP experience in cell therapy, biologics or pharmaceutical manufacturing or quality assurance.
• Technical writing skills.
• Advanced knowledge of GMP requirements and understanding of regulatory landscape.
• Knowledge of handling temperature-sensitive products including receiving, storage, labeling and packaging.
• Self-motivated and detail-oriented with absolute adherence to all related procedures.
• Computer skills including work with database programs (Access), spreadsheet programs (Excel) and word processing (Word).
• Communicate, read, and write legibly in English.
• Ability to follow guidelines of the Standard Operating Procedures (SOPs) for each operation in the process to conform to the Good Manufacturing Practice (GMP) and the Food and Drug Administration (FDA) Regulations.

Physical and Schedule Requirements

• Wear PPE (possible use of respirator), uniforms, and cleanroom gowns required by the Center policies and standard operating procedures.
• Work standing continuously for at least 2 hours.
• Visual acuity necessary to read displays and written instructions. Corrective lenses may be used provided that they meet the requirements for safety glasses, or safety glasses are worn over corrective lenses.
• Occasional weekend and evening work required.

PREFERRED QUALIFICATIONS:

• Experience working as a customer service provider.
• Background in biologics or cellular therapeutics.
• Experience working in a regulated (GxP) environment, including a thorough understanding of GMP record keeping and documentation practices.
• Strong administrative and logistics skills required to track a large variety and volume of tasks simultaneously.
• Experience with basic Microsoft Office Software (Word, Excel, Visio, etc.)
• Experience working in cellular therapeutics and/or biologics manufacturing environment.
• Experience generating GMP documents (SOPs, reports, specifications, etc.)

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

The annual base salary range for the I level position is from $67,445 to $101,167 and pay offered will be based on experience and qualifications.

The annual base salary range for the II level position is from $78,075 to $117,113, and pay offered will be based on experience and qualifications. Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).

Our Commitment to Diversity