Principal Engineer, Process Validation MSAT

About Artiva

We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies. For more information, visit www.artivabio.com.

About the role

As the Principal Engineer, Process Validation and member of the MSAT (Manufacturing Science & Technology) organization, you are responsible for the successful process validation activities for Artiva’s allogeneic manufacturing processes. In this role, you will lead manufacturing process validation in our biopharmaceutical plant, including assessment of process characterization, validation activities at scale, and continued process verification.

Responsibilities

• Author, execute, and document process validation protocols and reports in alignment with regulatory expectations (FDA, EMA, ICH) as well as studies intended to demonstrate the suitability and robustness of manufacturing processes.
• Support the full process validation lifecycle — Stage 1 (process design) through Stage 2 (PPQ) and Stage 3 (Continued Process Verification).
• Develop and maintain control strategy elements, process monitoring plans, and CPV trending.
• Manage technical risks associated with process validation and ensure project completion aligned with project management goals.
• Work closely with MSAT process experts as well as cross-functionally with QA, QC, PD, Manufacturing, and Regulatory Affairs to ensure communication of critical process and technical information to meet required deadlines.
• Compile assessments of change requests and process validation-related deviations in a timely manner.
• Author CMC sections in filing documents and technical content of validation reports.
• Participate in continuous improvement initiatives and the development of validation lifecycle strategies.
• Generously share information and knowledge across teams and functions.

Requirements

• Bachelor’s, Master’s, or PhD degree in biotechnology, chemical engineering, or related disciplines.
• Minimum 2 years of experience in process validation within a cGMP-regulated biopharmaceutical environment.
• Proven experience in managing complex projects.
• Experience in process development, process scale-up, and/or manufacturing is a plus.
• Strong technology transfer experience.
• Working experience in biopharma manufacturing and/or MSAT.
• Excellent technical writing skills with deep understanding of ICH, FDA, and EMA guidelines and GMP environment.
• Excellent communication and stakeholder management skills.

Benefits

• Comprehensive medical, dental, and vision insurance.
• Group life insurance.
• Long-term disability (LTD).
• 401(k) retirement plan.
• Employee Assistance Program (EAP).
• Flexible Spending Account (FSA).
• Paid Time Off (PTO).
• Company-paid holidays, including the year-end holiday week.
• Recognition program (Bonus.ly) where points earned can be redeemed for rewards.

Pay

Base Salary: $170,000 - $185,000. Exact compensation may vary based on level, skills, and experience.