Sr. Validation Engineer

About Us

Nkarta Therapeutics is a publicly traded (Nkarta NKTX symbol), South San Francisco headquartered, clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of allogeneic, off-the-shelf engineered natural killer, or NK, cell therapies to treat cancer and autoimmune disease.

Founded in 2015 at the birthplace of biotechnology, our development pipeline of engineered NK cell therapy candidates includes two co-lead clinical programs, NKX101 and NKX019 for the treatment of cancer and autoimmune disease. Nkarta also has a collaboration with CRISPR Therapeutics, a world leader in gene-based medicines, for the development and commercialization of up to three new cell therapy candidates and access to clinically validated CRISPR/Cas9 genome engineering.

 

Complementing our broad research and development capabilities, Nkarta has also built an extensive cell therapy manufacturing operation. We recently built out a 23,000-square foot clinical good manufacturing practice, or cGMP, facility on-site at our primary corporate location in South San Francisco, California.

Overview

Position Title       Sr. Validation Engineer

Location              South San Francisco

Reports to           Sr. Director Validation

 

Position Summary

Nkarta offers a unique opportunity for a highly motivated Sr. Validation Engineer to join our growing Validation team. This role supports the qualification and commissioning activities for the current manufacturing facility, including but not limited to equipment and facility. The role also supports the qualification of our new manufacturing suite and the eventual process qualification. It is a key position that will closely coordinate with internal and external partners in a cross-disciplinary Process Development, Manufacturing, Quality, and Facilities team to develop and implement best practices in qualification and validation at Nkarta.

Responsibilities

• Previous experience working with equipment, cleaning, facility, utility, computerized systems, and/or environmental monitoring qualifications.
• Proven record of successful execution in CQV programs
• Knowledge of common pharmaceutical industry validation life cycle guidelines 21 CFR Parts 210, 211, 11, EU Annex 11, GAMP 5, and Data Integrity, as well as ICH guidelines Q8, Q9, Q10
• Experience in multiple areas of validation, including facility/utilities, manufacturing/process, and/or QC laboratory equipment; software validation and data integrity, media fill/; environmental monitoring performance qualification (EMPQ)
• Experience with computer system validation and data integrity.
• Previous experience with GMP manufacturing cell therapy or biological products is a plus.
• Excellent verbal and written communication skills with the ability to communicate nuanced scopes and schedules with multiple dependencies.
• High degree of organization skills in terms of goal setting and achieving.
• Proficient in exercising sound judgment and flexibility while adapting to rapidly changing priorities, challenging situations, and deadlines needed to meet business objectives.
• Independence and creative problem-solving abilities; comfort working in the fluid structure of start-up biotech. 
• Integrity, confidence, passion, and collaborative spirit are highly valued.
• Embodies the Nkarta culture of empowerment, diversity, and inclusion.

Preferred

• Experience with cell therapy production processes and viral transduction principles and processes.

Qualifications

• Develop, implement, and manage a compliant, phase-appropriate validation program.
• Lead and participate in the creation, review, and execution of validation life-cycle documentation, including URS, FRS, protocols, and reports, as well as resolution of validation deviations, etc.
• Lead or assist in creating and revising documentation including Standard Operating Procedures (SOP), User Requirements Specifications (URS), System-Level Impact Assessments (SIA), Validation Master Plan (VMP), Validation Project Plans (VPP), and summary reports.
• Develop risk-based approaches to revalidation of products, processes, and systems.
• Ensure proper execution by following validation best practices validation strategy and maintain validation processes to achieve GMP/GDP compliance, company goals, and department objectives.
• Represent validation during inspections from regulatory agencies and internal audits.
• Maintain a constant state of inspection readiness by acting as the primary contact for internal and regulatory audits and driving audit observation corrective actions to closure.
• Work with IT validation partners (CSV) and user-group SMEs to implement QC and Manufacturing Systems for computer system validation and data integrity.
• Identify, design, and implement process and system improvements within Commissioning, Qualification, and Validation.

 

Education/Background

• Bachelor's degree in biological sciences, chemistry, chemical engineering, or another relevant life-science discipline
• +5 years of biopharmaceutical industry experience.

Working at Nkarta Inc.

This position requires the ability to lift and/or move up to 25 pounds occasionally. Specific vision abilities for this job include close vision, depth perception, and the ability to adjust focus. The standard requirements of an office environment (computers, computer screens, workstations, etc.) apply when not working in or around the laboratory environment. Car and airplane travel might be a requirement of this role.

 

A reasonable estimate of the current salary range for this position is $112,000 - $161,000. There are several factors taken into consideration in determining base salary, including but not limited to: job-related qualifications, skills, education, and experience, as well as the value of other elements of an employee's total compensation package. Nkarta also offers an annual discretionary bonus, equity grant(s), medical, dental, vision and life insurance coverage, in accordance with the terms and conditions of the applicable plans.  Other benefits include 401K plan, flexible spending account, ESPP, employee assistance program, paid vacation, holiday and personal days, paid parental, pregnancy, and bereavement leave.

The 150+ team members describe working at Nkarta through some of the following comments. While getting better work-life balance and improving communications between groups in an early stage start up environment are two areas on which we are working, here are real, anonymous comments about or regarding why people think Nkarta is a great place to work.

Employment Type: FULL_TIME