Principal Engineer, Process Validation MSAT

artivabio; San Diego (CA); On-site; USD 170,000 - 185,000; Full time

Benefits offered by this job

Beautiful facility

Collaborative environment

Comprehensive benefits including: Med,

401(k) Retirement Plan

PTO and holidays

Bonus.ly recognition program

Job summary

Artiva is seeking a Principal Engineer, Process Validation, to lead validation activities for allogeneic manufacturing. You’ll manage validation from design through continued verification in a biopharma plant, coordinating with MSAT, QA, QC, and Regulatory Affairs.

You will author protocols, monitor CPV trends, and drive lifecycle strategies while ensuring regulatory compliance (FDA/EMA/ICH) with robust documentation and risk management.

Qualifications

• Bachelor’s, Master’s or PhD 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 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.

Responsibilities

• Author, execute, and document process validation protocols and reports per regulatory expectations (FDA, EMA, ICH).
• Support the full process validation lifecycle — Stage 1 through Stage 3.
• Develop and maintain control strategy elements, process monitoring plans, and CPV trending.
• Manage technical risks and align with project management goals.
• Collaborate with MSAT, QA, QC, PD, Manufacturing and Regulatory Affairs to meet deadlines.
• Compile assessments of change requests and deviations.
• Author CMC sections in filing documents and validation reports; contribute to lifecycle strategies.
• Share information across teams with high integrity.

Skills

Project management

Process validation

Technical writing

Regulatory knowledge

MSAT experience

Stakeholder management

Biopharma experience

Education

Bachelor’s/Master’s/PhD in biotechnology or related disciplines

Job description

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 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.

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.

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

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.