GMP Facilities Engineer

Employer
Nkarta Inc
Location
South San Francisco, CA, United States
Posted
Oct 05, 2020
Ref
29245
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
GMP Facilities Engineer

Founded at the birthplace of biotechnology, Nkarta's mission is to discover, develop and deliver novel off-the-shelf (e.g. allogeneic) natural killer (NK) cell therapies that profoundly impact patients' outcomes and survival . The company is based on the proprietary, robust and well-characterized NK cell expansion technology pioneered by Dr. Dario Campana. Nkarta is focused on leveraging the inherent power of NK cells to identify and kill abnormal cells and recruit adaptive immune effectors to generate responses that are deep and durable.

Nkarta combines its NK cell expansion and cryopreservation platform with proprietary cell engineering technologies to generate an abundant supply of NK cells, engineer enhanced NK cell recognition of tumor targets, and improve persistence for sustained activity in the body for the treatment of cancer.

Founded in 2015, Nkarta became a public company (Nasdaq symbol NKTX) in 2020. Our development pipeline of engineered NK cell therapy candidates consists of two co-lead programs, NKX101 and NKX019. The IND for NKX101 for the treatment of relapsed or refractory AML and higher-risk MDS was accepted by the FDA in July 2020. We expect to begin dosing patients in this study by the end of 2020. As we broaden the development of NKX101, we also plan to initiate studies in solid tumors. Our second co-lead program, NKX019, is designed to target B cell lymphomas. We plan to file our IND for NKX019 with the FDA in early 2021. In addition, we recently completed the construction of a GMP compliant clinical manufacturing facility in our South San Francisco location designed to produce viral vector and supply our initial clinical trials.

Position Title GMP (Good Manufacturing Practices) Facilities Engineer

Location South San Francisco, CA

Reports to Associate Director, Operations and IT

Position Summary

This role is key in supporting the startup, certification and ongoing production and maintenance of Nkarta's clinical GMP manufacturing facility and the expansion of the operation to include the capability of the facility to produce retroviral vectors, stimulatory cell lines and clinical manufacturing of NKX101.

Key Responsibilities
• Works cross functionally with various vendors to develop and execute commission and validation packages (i.e. protocols, final reports, creation of SOPs) related to the facility systems (facilities/HVAC/utilities systems).

• Generates design specifications as well as other engineering-related documentation to support facility, and utility qualifications and commissioning.

• Oversees equipment enrollment, maintenance, and calibration.

• Leads the installation of equipment for the manufacturing and quality control areas.

• Develops and executes equipment maintenance and calibration programs.

• Works closely with vendors and internal teams for preparation and execution of protocols for validation of HVAC, environmental monitoring, utilities, and clean rooms.

• Works with vendors validating and sustaining the environmental monitoring and control systems (building management systems).

• Investigates, troubleshoots, and resolves problems which occur during facility qualification and routine operations tied to the facility, manufacturing equipment, and laboratory equipment in the R/D areas.

• Coordinates with the building landlord for cases where the landlord provides for certain access and control around the maintenance of certain utilities.

• Assesses impact of change control to qualified systems to ensure a state of compliance is maintained.

• Follows FDA and other regulatory agency cGMP regulations/requirements for facilities and utilities for manufacturing.

• Establishes and maintains cross functional relationships with manufacturing, and quality operations.

• Able to manage competing priorities and maintain tight timelines.

• Works cross-functionally and consults frequently Manufacturing, Quality, and Project Management.

• Manages the resources and the operations of Nkarta's GMP facility with regards to administrative processes, and maintenance of a fully functional GMP facility, and labs.

• Provides oversight and guidance for the repair of basic facility equipment and necessary facility repairs.

• Assists manufacturing management with security, safety, emergency preparedness, and environmental health needs.

• Provides oversight with inspections and audits of facility to understand how to ensure the build out is correctly managed.

• Manages inspections and audits of the facility related to CalOSHA, fire safety, etc.

• Participates in regulatory audits of the facility.

• Selects and manages vendors and contractors tied to the facility maintenance and equipment calibration.

• Assists in preparation of annual facilities operating budgets, and capital improvement budgets tied to facility upgrades.

• Embodies the Nkarta culture of empowerment, diversity, and inclusion.
• Provide exemplary customer service to all stakeholders.

Position Requirements
• Strong mechanical aptitude and troubleshooting abilities.

• Working knowledge of cGMP guidelines and compliance within controlled space.

• Strong knowledge of manufacturing utility systems (water, air, HVAC, etc.).

• Biopharma experience or similar regulated manufacturing.

• Ability to read and interpret engineering documents.

• Understanding of IOT (Internet of Things) and strong knowledge of computerized management systems.

• Strong ability to multitask, work in a fast pace environment, and maintain a high level of customer service.
• Detail orientated paired with excellent leadership and communication skills, both oral and written.

Education / Background
• 10+ years of experience in Facilities/HVAC/utilities systems for a pharmaceutical company (facility management focus), or a BA or BS degree, or a MS degree with minimum 7 years of experience.

• Experience commissioning or validating a new facility is desired, as well as experience in documentation requirements tied to commissioning and validation of Facilities/HVAC/utilities systems.
• Understanding and experience with FDA cGMP regulations/requirements for facilities and utilities for manufacturing.

Working Environment

This position requires the ability to occasionally lift and/or move up to 50 pounds. Specific vision abilities for this job include close vision, depth perception, and ability to adjust focus. Must be able and willing to work around production and manufacturing equipment including tight, narrow and above ground spaces. Extensive manual dexterity required. The common requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around the laboratory and production environments. Off shift hour work may be needed at times to accommodate installations or emergencies.

About Nkarta

The 70+ team members at our South San Francisco, California headquartered location describe working at Nkarta, along with opportunities for improvement, in some of the following ways:

• "Work is interesting - lots of projects in the pipeline (so I don't have to worry about the one project failing). Leadership is open, straight forward."
• "Smart, capable, nice people. People I work with day to day are enjoyable."
• "Employee-centric."
• "I like that the company is open minded with a (people) -(looking for) a set of skills that can grow (as opposed to thinking you have to have exactly what's in a job spec now) Things that broaden their (employees) skills and growth."
• "Like any startup there are fires to put out; feel confident we have the people to control those fires."

• "Diverse people from different backgrounds."

To learn more about our work at Nkarta and the career opportunities that will drive us forward to serve patients, please visit the company's website at https://www.nkartatx.com