Process Development Engineer

Crystal Equation Corporation; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Crystal Equation Corporation seeks a candidate with a B.S. or M.S.

in a scientific or engineering discipline to support Process Development and Technology Transfer activities across multiple product lines at aseptic fill-finish facilities in Thousand Oaks, CA. You will plan, execute, and document characterization, process validation, and tech transfer projects, generating technical data packages and communicating findings to cross-functional groups.

Qualifications

• B.S. in a scientific or engineering discipline with 1+ years of experience, or M.S. in a scientific or engineering discipline.
• Familiarity with cGMP and experience in drug product or drug substance manufacturing or process development.
• Knowledge of and hands-on experience with various drug product technologies.
• Demonstrated critical-thinking, problem-solving, and independent research skills.
• Ability to learn new techniques, perform multiple tasks, maintain accurate records, follow instructions, and comply with company policies.
• Excellent project management skills and the ability to elevate relevant issues to the project lead and line management.
• Strong cross-functional teamwork and effective oral and written communication skills.
• Ability to work independently and collaboratively with internal and external partners.
• Strong computer and organizational skills, with close attention to detail.

Responsibilities

• Apply fundamental engineering and scientific principles to resolve issues and evaluate effects of process improvements, equipment, scale, and raw materials.
• Assist in design and execution of experiments to characterize and enable implementation of new capabilities and process changes, such as filling, lyophilization, and analytical technologies.
• Support technology transfer leads during transfer of drug products to clinical and commercial manufacturing sites, including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments.
• Support the development and maintenance of clinical and commercial technology transfer tools.
• Effectively communicate results of characterization studies, experimental execution, and technology transfer initiatives.
• Author, review, and data-verify technical documents, such as technical protocols, technical assessments, technical reports, draft SOPs, and guidance documents.
• Analyze generated data, including performing statistical analyses using Minitab, JMP, or similar software.
• Develop digital tools and models by leveraging data analytics and programming skills.
• Support at-scale characterization and/or process validation runs as a person in plant.

Skills

Problem solving

Project management

Data analytics

Programming skills

Communication

Independent research

Cross-functional teamwork

Education

B.S. in scientific or engineering

M.S. in scientific or engineering

Tools

SAP

Smartsheet

Minitab

JMP

Job description

The ideal candidate for this role should have a bachelor’s degree in a scientific or engineering discipline. The candidate should have experience with software tools beyond Microsoft Office, such as SAP or Smartsheet, although these tools can be learned on the job. This position emphasizes process development (PD) and project management (PM) skills, with technical expertise expected to develop over time.

As a member of the Process Development team, you will support senior staff in developing and characterizing drug product technologies and manufacturing capabilities. The candidate will also assist with process validation and technology transfer activities for multiple products across various production lines at the aseptic fill-finish manufacturing facilities in Thousand Oaks.

You will support senior staff in planning, executing, and documenting characterization, process validation, and technology transfer projects. The candidate will be primarily responsible for executing characterization studies and other experiments at laboratory and production scales to generate technical data packages using complex technologies, while organizing data and analyzing results under the supervision of senior staff.

You will interface with various drug product teams to support the successful technology transfer of products and the associated documentation. The candidate will assist in establishing experimental designs, developing and executing protocols, obtaining reproducible and reliable results, analyzing and documenting experimental results, and communicating findings to cross-functional groups

Responsibilities:

• Apply fundamental engineering and scientific principles to resolve issues and evaluate the effects of process improvements, equipment, scale, and raw materials.
• Assist in the design and execution of experiments to characterize and enable the implementation of new capabilities and process changes, such as filling, lyophilization, and analytical technologies.
• Support technology transfer leads during the transfer of drug products to clinical and commercial manufacturing sites, including make-a-batch exercises, process parameter risk assessments, process transfer documents, and change control assessments.
• Support the development and maintenance of clinical and commercial technology transfer tools.
• Effectively communicate the results of characterization studies, experimental execution, and technology transfer initiatives.
• Author, review, and data-verify technical documents, such as technical protocols, technical assessments, technical reports, draft standard operating procedures, and guidance documents.
• Analyze generated data, including performing statistical analyses using Minitab, JMP, or similar software.
• Develop digital tools and models by leveraging data analytics and programming skills.
• Support at-scale characterization and/or process validation runs as a person in plant.

Preferred Qualifications:

• B.S. in a scientific or engineering discipline with 1+ years of experience, or M.S. in a scientific or engineering discipline
• Familiarity with cGMP and experience in drug product or drug substance manufacturing or process development.
• Knowledge of and hands-on experience with various drug product technologies.
• Demonstrated critical-thinking, problem-solving, and independent research skills.
• Ability to learn new techniques, perform multiple tasks, maintain accurate records, follow instructions, and comply with company policies.
• Excellent project management skills and the ability to elevate relevant issues to the project lead and line management.
• Strong cross-functional teamwork and effective oral and written communication skills.
• Ability to work independently and collaboratively with internal and external partners.
• Strong computer and organizational skills, with close attention to detail.