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Artiva Biotherapeutics is a clinical-stage biotechnology company developing natural killer (NK) cell-based therapies for autoimmune diseases. The company's lead product, AlloNK®, is a non-genetically modified, cryopreserved NK cell therapy designed for use in community settings.
As Principal Engineer, Process Validation within the Manufacturing Science & Technology (MSAT) organization, you will lead process validation activities for Artiva's allogeneic manufacturing processes. You will be responsible for the full process validation lifecycle—from Stage 1 (process design) through Stage 2 (PPQ) and Stage 3 (Continued Process Verification)—ensuring manufacturing processes meet regulatory expectations and demonstrate suitability and robustness.
Key responsibilities include:
- Authoring, executing, and documenting process validation protocols and reports aligned with FDA, EMA, and ICH regulatory expectations
- Developing and maintaining control strategy elements, process monitoring plans, and CPV trending
- Managing technical risks associated with process validation and ensuring project completion aligned with timelines
- Collaborating cross-functionally with MSAT process experts, QA, QC, Product Development, Manufacturing, and Regulatory Affairs
- Assessing change requests and process validation deviations
- Authoring CMC sections in regulatory filing documents and technical content of validation reports
- Participating in continuous improvement initiatives and validation lifecycle strategy development
- Sharing knowledge and information across teams with high integrity
Required qualifications:
- Bachelor's, Master's, or PhD in biotechnology, chemical engineering, or related discipline
- Minimum 2 years of process validation experience in a cGMP-regulated biopharmaceutical environment
- Proven experience managing complex projects
- 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 environments
- Excellent communication and stakeholder management skills
Process development, scale-up, and manufacturing experience are valued additions.
