Senior MSAT Engineer - Tech Transfer (Biotech)

artivabio; San Diego (CA); On-site; USD 150,000 - 165,000; Full time

Benefits offered by this job

Medical

Dental and Vision

401(k) Plan

Employee Assistance Program (EAP)

Flexible Spending Account (FSA)

Paid Time Off (PTO)

Company paid holidays

Job summary

Artiva is seeking a Sr. Manager, MSAT Engineer to lead tech transfer and process validation for late-stage clinical and commercial manufacturing.

You will drive documentation, troubleshooting, investigations and CAPA in a fast-paced, regulated environment. You have advanced degrees in biotech or chemical engineering, strong project management skills, and hands-on experience with cGMP, IQ/OQ/PQ, and aseptic processing.

Qualifications

• Bachelor’s, Master’s or PhD in biotech or chemical engineering.
• Experience managing complex projects in pharma/biotech.
• Technical depth in late-stage clinical and commercial manufacturing.
• Ability to establish business processes and governance.
• Strong interpersonal and communication skills.
• Cell culture, cell therapy or aseptic processing experience.
• Experience with IQ/OQ/PQ and process validation in cGMP.
• Proactive and adaptable with willingness to take on temporary duties.

Responsibilities

• Support tech transfer and validation for manufacturing projects.
• Write Master Batch Records, SOPs, deviations, and risk assessments.
• Lead deviations with QA and perform root cause analysis.
• Monitor production for process issues and troubleshoot.
• Author investigations and drive CAPA.
• Support raw materials characterization and risk assessment.
• Create dashboards to visualize manufacturing data.
• Establish Track and Trend program with biostatistics.
• Other duties as assigned.

Skills

Project management

Process engineering

cGMP knowledge

Root cause analysis

Documentation

Communication skills

Cell culture experience

IQ/OQ/PQ

Regulated engineering

Education

Bachelor’s/Master’s/PhD in biotechnology or chemical engineering

Job description

Artiva is seeking a Sr. Manager, MSAT Engineer to lead tech transfer and process validation for late-stage clinical and commercial manufacturing.

You will drive documentation, troubleshooting, investigations and CAPA in a fast-paced, regulated environment. You have advanced degrees in biotech or chemical engineering, strong project management skills, and hands-on experience with cGMP, IQ/OQ/PQ, and aseptic processing.