Job Description:

• Job Title: Process Development Engineer
• Location: Thousand Oaks, CA 91320
• Working Schedule: Onsite (8:00 AM – 5:00 PM, Local Time)
• Duration: 12 Months (possibilities of extension or conversion to FTE)

Role Overview:

We are seeking a skilled Process Development Engineer who can work independently to support technical projects within drug product development and manufacturing. This role involves hands-on laboratory work, process development, technical transfer, and strong documentation practices. Excellent communication and technical writing skills are essential.

Key Responsibilities

• Author, data verify, and review guideline documents, technical protocols, reports, and product impact assessments
• Execute laboratory analytical testing including viscosity, protein concentration, pH, and osmolality
• Perform laboratory experiments such as pipetting, formulation, and filtration
• Provide technical support for drug product process development, including formulation, filtration, and filling (vials/syringes/devices) of parenteral products
• Assist in development, characterization, and technology transfer of drug product processes to commercial sterile fill/finish sites
• Support commercial drug product process development activities including sterile processing, process characterization, tech transfer, and validation
• Collaborate with manufacturing and cross-functional teams to support commercial manufacturing operations
• Participate in global, cross-functional, matrixed teams
• Troubleshoot drug product processing technologies and equipment using data-driven root cause analysis

Basic Qualifications

• Master’s degree OR
• Bachelor’s degree with 2+ years of experience OR
• Associate degree with 6+ years of experience OR
• High School diploma/GED with 8+ years of experience

Top 3 Must Have Skill Sets

Post graduation experience require

1. laboratory experience using analytical equipment
2. evidence of good communication e.g. writing documents and sharing results
3. college degree in engineering or similar (chemical engineer, bio engineer, pharmaceutical science, etc)

Day-to-Day Responsibilities

• Onsite laboratory work (e.g., viscosity testing using a rheometer)
• Maintaining strong documentation practices using laboratory notebooks
• Analyzing, summarizing, and communicating experimental results
• Documentation and data verification