Principal Engineer, Process Validation – Biopharma 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

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.