Regulatory/CPP Admin Coordinator

SSi People; Thousand Oaks (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in California is seeking a skilled Process Development Engineer to support technical projects in drug product development and manufacturing. The ideal candidate will have strong lab skills, including analytical testing and documentation practices. This role requires a bachelor’s degree in engineering or a related field, along with relevant experience. Excellent communication and technical writing skills are essential. This position involves onsite work with a potential duration of 12 months, with opportunities for extension or conversion to full-time employment.

Qualifications

• Bachelor's degree with 2+ years of experience or an equivalent combination of education and experience.
• Strong laboratory skills to conduct analytical testing and experiments.
• Excellent documentation and technical writing skills.

Responsibilities

• Author guidelines and reports for drug product development.
• Perform lab experiments and analytical testing.
• Collaborate with teams to support manufacturing operations.

Skills

laboratory experience using analytical equipment

good communication skills

knowledge in engineering or similar field

Education

Bachelor’s degree in engineering or related field

Associate degree

High School diploma/GED

Job description

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.

• Working Schedule: Onsite (8:00 AM – 5:00 PM, Local Time)
• Duration: 12 Months (possibilities of extension or conversion to FTE)

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

• 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

• laboratory experience using analytical equipment
• evidence of good communication e.g. writing documents and sharing results
• 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