Aseptic Process Development Engineer: Tech Transfer & Validation

3 Key Consulting, Inc.; Thousand Oaks (CA); On-site; USD 56,000 - 63,000; Full time

Job summary

3 Key Consulting, Inc. is seeking a Process Development Engineer for aseptic fill-finish, tech transfer, and validation in Thousand Oaks, CA on a contract basis. The role emphasizes PD and PM with potential extensions.

Bachelor or Master degrees and experience in drug manufacturing environments are valued. The candidate will support characterization, validation, and technology transfer activities across multiple lines, coordinating with cross-functional teams to generate robust data packages and

Qualifications

• Bachelor's or Master’s degree in science or engineering with applicable experience.
• Experience with software tools beyond Microsoft Office, such as SAP or Smartsheet.
• Drug product knowledge not required but helpful; strong documentation skills.

Responsibilities

• Apply engineering and scientific principles to resolve process issues and evaluate improvements.
• Design and execute experiments to characterize capabilities and enable process changes.
• Support technology transfer leads during drug product transfers to clinical and commercial sites.
• Develop and maintain technology transfer tools and data analytics solutions.
• Communicate results and document protocols, assessments, and reports.

Skills

Cross-functional communication

Critical thinking

Accountability

Drug manufacturing experience

Education

Master's degree

Bachelor's degree + 2 years

Associate degree + 6 years

High school diploma / GED + 8 years

Tools

SAP

Smartsheet

Minitab

JMP

Job description

3 Key Consulting, Inc. is seeking a Process Development Engineer for aseptic fill-finish, tech transfer, and validation in Thousand Oaks, CA on a contract basis. The role emphasizes PD and PM with potential extensions.

Bachelor or Master degrees and experience in drug manufacturing environments are valued. The candidate will support characterization, validation, and technology transfer activities across multiple lines, coordinating with cross-functional teams to generate robust data packages and