Aseptic Fill-Finish Engineer - Tech Transfer & Validation

3key Consulting, Inc.; Thousand Oaks (CA); On-site; USD 117,482,000 - 131,809,000; Full time

Job summary

3 Key Consulting is seeking a Process Development Engineer for aseptic fill-finish, tech transfer and validation on a contract basis in Thousand Oaks, CA. The role emphasizes PD and PM skills, with the opportunity to develop technical expertise while supporting multiple products across production lines.

The ideal candidate has a bachelor’s in science or engineering, with potential master’s consideration, and can coordinate cross-functionally, meet deadlines, and maintain rigorous documentation

Qualifications

• Bachelor’s degree in a scientific or engineering discipline; master’s degree preferred if strong communication skills.
• Experience with software tools beyond Microsoft Office, such as SAP or Smartsheet.
• Prior drug product knowledge not required; strong coordination, deadlines, and meticulous documentation.
• PD/PM focus with potential to develop technical expertise over time.

Responsibilities

• Apply fundamental engineering and scientific principles to resolve issues and evaluate process improvements, equipment, scale, and materials.
• Design and execute experiments to characterize and enable implementation of new capabilities and process changes (filling, lyophilization, analytical technologies).
• Support technology transfer leads during transfer of drug products to clinical and commercial sites, including make-a-batch exercises and change control assessments.
• Develop and maintain technology transfer tools, data analytics solutions, and process models.

Skills

Cross-functional communication

Critical thinking

Accountability

Drug manufacturing knowledge

Education

Bachelor's degree in science or engineering

Master's degree (preferred)

Tools

SAP

Smartsheet

Minitab

JMP

Job description

3 Key Consulting is seeking a Process Development Engineer for aseptic fill-finish, tech transfer and validation on a contract basis in Thousand Oaks, CA. The role emphasizes PD and PM skills, with the opportunity to develop technical expertise while supporting multiple products across production lines.

The ideal candidate has a bachelor’s in science or engineering, with potential master’s consideration, and can coordinate cross-functionally, meet deadlines, and maintain rigorous documentation