Lead Lipid MLV Process Validation Engineer

Aerogen Ltd.; Foster City (CA); On-site; USD 138,000 - 165,000; Full time

Benefits offered by this job

Performance-based incentive bonus

Medical, Dental, Vision

401k Retirement

PTO

Global EAP Program

Disability & FMLA Benefits

Job summary

Aerogen Pharma is seeking a Senior Process Validation Engineer to own validation strategy for late-stage and commercial lipid MLV drug products. You will lead process characterization, PPQ, and technology transfer with MSAT and CDMO partners.

The role requires extensive GMP experience, DOE/JMP expertise, and strong cross-functional leadership to drive quality and regulatory readiness across programs.

Qualifications

• Bachelor’s or Master’s degree in chemical, biochemical, pharmaceutical, mechanical, or biomedical engineering; advanced degree preferred.
• Typically 8+ years in pharmaceutical/process validation, GMP environment, and ownership of validation deliverables.
• Demonstrated leadership of at least one late-stage or commercial PPQ campaign.

Responsibilities

• Develop and maintain validation strategy and master plan for lipid MLV products and CPV.
• Lead process characterization, CQAs/CMAs/CPPs, and readiness reviews.
• Author PPQ protocols, sampling plans, and deviation/ CAPA investigations.
• Support regulatory submissions and inspection readiness across IND/BLA/NDA contexts.

Skills

Process-validation

DOE

JMP

GMP

Program leadership

Education

Bachelor's or Master's in chemical/biomedical/pharma

Tools

JMP

Job description

Aerogen Pharma is seeking a Senior Process Validation Engineer to own validation strategy for late-stage and commercial lipid MLV drug products. You will lead process characterization, PPQ, and technology transfer with MSAT and CDMO partners.

The role requires extensive GMP experience, DOE/JMP expertise, and strong cross-functional leadership to drive quality and regulatory readiness across programs.