Process Development Engineer – Aseptic Fill-Finish, Tech Transfer & Validation (JP15893)

3 Key Consulting • Thousand Oaks, CA

1d • Onsite

About The Position

The Process Development Engineer – Aseptic Fill-Finish, Tech Transfer & Validation will support senior staff in developing and characterizing drug product technologies and manufacturing capabilities. This role will also assist with process validation and technology transfer activities for multiple products across various production lines at aseptic fill-finish manufacturing facilities. The candidate will be responsible for executing characterization studies and other experiments at laboratory and production scales, organizing data, and analyzing results under supervision. This position emphasizes process development and project management skills, with technical expertise expected to develop over time. The candidate will interface with various drug product teams to support the successful technology transfer of products and associated documentation.

Requirements

• Bachelor’s degree in a scientific or engineering discipline.
• Experience with software tools beyond Microsoft Office, such as SAP or Smartsheet.
• Excel in group coordination, meeting deadlines, and maintaining meticulous documentation.
• Process development (PD) and project management (PM) skills.
• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
• B.S. in a scientific or engineering discipline with 1–3 years of experience, or M.S. in a scientific or engineering discipline with 0–2 years of experience.
• Familiarity with cGMP.
• 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 escalate 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.
• Self-motivated with a positive attitude.

Nice To Haves

• Recent master’s degree with strong interpersonal and communication skills.
• Prior drug product knowledge.
• Experience with SAP or Smartsheet (can be learned on the job).
• Experience with drug manufacturing processes or drug substances.
• Experience in drug product or drug substance manufacturing or process development.
• Knowledge of and hands-on experience with various drug product technologies.

Responsibilities

• Support senior staff in planning, executing, and documenting characterization, process validation, and technology transfer projects.
• Execute characterization studies and other experiments at laboratory and production scales to generate technical data packages using complex technologies.
• Organize data and analyze results under the supervision of senior staff.
• Interface with various drug product teams to support the successful technology transfer of products and the associated documentation.
• 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.
• 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.
• Support the planning, execution, and documentation of process development, characterization, process validation, and technology transfer activities.
• Execute laboratory- and production-scale experiments, including protocol preparation, experimental setup, and data collection.
• Organize, analyze, and interpret technical data using tools such as Minitab, JMP, SAP, and Smartsheet.
• Track project activities, deliverables, and timelines while proactively communicating risks or delays.
• Collaborate with cross-functional teams and manufacturing sites to support drug product technology transfers.
• Assist with process risk assessments, change control evaluations, make-a-batch exercises, and transfer documentation.
• Communicate study results, technical findings, and project updates to senior staff and cross-functional stakeholders.
• Support characterization and process validation runs at manufacturing scale as a person in plant.
• Develop and maintain technology transfer tools, data analytics solutions, and process models.

Benefits

• Supplement additional workload on team

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level