Process Engineer II

Описание вакансии

Kite is seeking a highly motivated individual with cell therapy or biologics manufacturing experience to provide manufacturing support for a new commercial Cell Therapy manufacturing facility in Frederick, MD. The Process Engineer II position is a key technical role within the Manufacturing Science and Technology (MSAT) organization. This role will provide process engineering support for the validation and commercial manufacturing of cell therapy products. Working cross functionally with quality, operations, process development, and facility/engineering functions, the role is expected to provide technical input for deviation investigations, new technology implementation, technology transfers, process validation, and regulatory filings.

Key responsibilities:

• Support development of data analytics tools including SQL queries and JMP scripts.

• Monitor and analyze manufacturing data to provide support for investigations, continued process verification, and process improvements.

• Serve as a subject matter expert to lead product impact assessments for deviations.

• Participate in process FMEAs to understand process and product risks to support tech transfer and product lifecycle management.

• Participate and report to a cross-functional team to advance production activities and site capabilities.

• Identify continuous improvement opportunities and support implementation in Manufacturing through Operational Excellence

• Ensure a systematic DMAIC based approach is utilized for process/product related investigations to identify root cause and provide impact assessment to support routine manufacturing operations and determine process improvements for manufacturing.

• Support technology transfers for launch and commercialization of cell therapy products.

• Provide technical expertise to support regulatory filings and health authority questions.

• Effectively summarize and communicate manufacturing process performance internally and externally.

• Support the implementation of automation and IT infrastructure projects.

• Design and execute laboratory studies to support process/product understanding and continuous improvement projects

• Author technical documents (protocols reports for laboratory studies, comparability, and process validation)

Basic Qualifications

• Master’s Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or Life Sciences with 2+ years of industry experience.

OR

• Bachelor’s Degree in Biochemical Engineering, Chemical Engineering, Biotechnology or Life Sciences with 4+ years of industry experience.

Preferred Qualifications:

• Cell therapy experience

• Demonstrated knowledge of biopharmaceutical manufacturing, aseptic processing, cell therapy, and process development

• Practical expertise with cGMP manufacturing and regulatory requirements

• In-depth understanding of scientific and engineering principles

• Experience in statistical analysis using JMP or Minitab

• Experience with SQL queries and cloud databases

• Knowledge of data management tools and statistical process controls

• Process validation experience including support for regulatory filings and inspections

• Ability to think critically, with demonstrated troubleshooting and problem-solving skills

• Excellent interpersonal, verbal and written communication skills

• Ability to function efficiently and independently in a fast-paced environment

• Self-motivated and willing to accept temporary responsibilities outside of initial job description

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