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Principal Engineer, Process Validation MSAT

artivabio
Companyartivabio
CategoryEngineering
LocationSan Diego
RemoteOn-site (inferred)
EmploymentNot stated
LevelLead
SalaryNot stated by the employer
First seen25 Jul 2026 (the employer did not state a posting date)
Last verified11 Aug 2026
SourceEmployer ATS (bamboohr)
Applications are handled by the employer, not by us.Apply on the employer's site →
Description
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 . Job Summary : 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   be responsible for   manufacturing process validation in our biopharmaceutical plant, including assessment of process characterization, validation activities at scale and continued process verification. Duties/ Responsibilities: • Responsible for  authoring , execution, and documentation of  process  validation protocols and reports in alignment with regulatory expectations (FDA, EMA, ICH) as well as of 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. • Responsible for the management of technical risks associated with process validation, and project completion aligned with project management goals. • Works 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 of  technical information to meet the required deadlines. • Ensures  timely  compilation of assessments of change requests and process validation related deviations. • Responsible to  author  CMC sections in filing documents and technical content of validation reports. Participates in continuous improvement initiatives and in the development of  validation  lifecycle strategies. • Generously shares information and knowledge with  other across  teams and functions. Demonstrates high integrity. • 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. Requirements: • Bachelor’s,   Master’s   or   PhD  degree   in biotechnology, chemical engineering or related disciplines. • Proven experience in managing complex projects. • Minimum 2 years of experience in process validation within a cGMP-regulated biopharmaceutical environment. Experience in process development, process   scale up   and / or manufacturing is a plus. • Strong technology transfer experience   necessary . • Working   experience i n 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. In addition to a great culture, we offer: • A beautiful facility • An entrepreneurial, highly collaborative, and innovative environment • Comprehensive benefits, including: • Medical, Dental, and Vision • 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 • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. If all this speaks to you, come join us on our journey! Base Salary: $ 170,000 - $185,000. Exact compensation may vary based on level, skills and experience.