Senior Process Validation Engineer – Lipid MLV & PPQ Lead

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

Job summary

Aerogen Pharma seeks a Senior Process Validation Engineer to lead validation strategy and execution for lipid MLV products in late-stage and commercial manufacture. You will drive process characterization, PPQ, CPV, and cross-functional transfer with MSAT, Quality, and Regulatory teams.

The role requires extensive GMP experience, leadership of PPQ campaigns, and collaboration with CDMOs, Regulatory CMC, and manufacturing partners to ensure data integrity and a state of control.

Qualifications

• Bachelor's or Masters in chemical, biochemical, pharmaceutical, mechanical, or biomedical engineering; advanced degree preferred.
• Typically 8+ years of pharma or biopharma process, manufacturing, MSAT, or validation experience, including at least 5 years in GMP.
• Demonstrated leadership of at least one late-stage or commercial PPQ campaign from protocol strategy to transfer into CPV.
• Direct experience with lipid-based, liposomal, vesicular, emulsion, or other complex colloidal drug products. Expertise in MLV formation and scale-up is preferred.

Responsibilities

• Develop and maintain the product/process validation strategy and master-plan inputs.
• Translate development and scale-up knowledge into CQAs, CMAs, CPPs, and acceptance criteria.
• Define and validate controls for lipid MLV manufacturing operations and final processing.
• Lead PPQ protocol design, sampling plans, run prerequisites, and final reporting with cross-functional reviews.
• Support sterile and aseptic processing validation, depyrogenation, and container-closure testing.
• Oversee CGMP alignment, data integrity (ALCOA+), and regulatory-ready validation content.

Skills

Process validation

GMP

PPQ

Statistics & DOE

Project leadership

Education

Bachelor's or Master's in chemical/biomedical/pharm eng

Advanced degree preferred

Tools

JMP

Sterile processing equipment

Job description

Aerogen Pharma seeks a Senior Process Validation Engineer to lead validation strategy and execution for lipid MLV products in late-stage and commercial manufacture. You will drive process characterization, PPQ, CPV, and cross-functional transfer with MSAT, Quality, and Regulatory teams.

The role requires extensive GMP experience, leadership of PPQ campaigns, and collaboration with CDMOs, Regulatory CMC, and manufacturing partners to ensure data integrity and a state of control.