Senior Process Engineer I, Process Validation - Biotech

Description de l'emploi

We are seeking a highly motivated leader to join as a Sr. Process Engineer I in Global Manufacturing Sciences and Technology (MSAT) Validation. This individual will provide technical leadership for qualification, product comparability and process validation for both clinical and commercial cGMP manufacturing for Kite’s engineered autologous T cell therapy products and viral vector programs for both domestic and overseas production sites. As a Sr. Process Engineer I Grade 28 in the Process Validation and Comparability group you will define technical requirements and author and approve comparability and process validation project master plans, protocols and reports. In addition, this role will include development of strategic cGMP campaign planning for Stage 2 Process Performance Qualification (PPQ) and will include but not limited to authorship of product impact and risk assessments, regulatory submission sections, resolution of deviations and/or excursions, oversight of validation and/or comparability activities in cGMP manufacturing, department policies and/or procedures and technical reports Additionally, there will be review of Stage 3 Continuous Process Verification (CPV) trending reports and analysis to establish robust, consistent and reliable long term manufacturing operations. Finally, the qualified candidate will work with the Process Design/Development, Manufacturing and Quality teams to implement cell therapy processes to multiple sites, establish novel technology and site qualification strategies and will lead all aspects of process validation, as well as draft documentation for regulatory filings to advance Kite’s product portfolio.

Responsibilities:

• Author, Review and Approve validation documentation such as validation master plans, protocols & reports for PPQ and comparability and cell therapy manufacturing process validation testing in alignment with Kite Global SOPs.
• Support, develop and implement scientifically sound and fit for purpose global validation plans, policies and procedures based on current regulations, industry standards and industry practices for cell therapy.
• Present to stakeholders on strategic plans and/or justification of business-critical activities
• Develop process validation standards, process qualification (PQ) strategy and framework for cell therapy processes, CPV strategy and implementation for a wide variety of products across the global network of sites. This includes contributing to the validation requirements for implementation of aseptic validation or closed system processing.
• Develop and maintain qualification responsibilities include technical support for equipment qualification standards, framework for harmonized risk-based qualification strategies for similar equipment and unit operations across plants and alignment of PQ activity with process and operational requirements.
• Based on product and process lifecycle requirements, define and establish sound scientific approaches for risk evaluation of global process change impact on process validation and comparability.
• Interface internally with process design, analytical development, technical development, Global/Site MSAT and process technical leads and cross-functionally with Quality, Manufacturing and Engineering to implement new processes and technology as part of technology transfers.
• Participate in evaluation of new technology and process automation for introduction into GMP manufacturing.
• Support investigation, identify root cause for critical deviations during process validation and resolve CAPA for manufacturing.
• Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and solving equipment process issues.

Basic Qualifications:

• MS Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 5+ years of biotechnology and/or cell therapy experience
• BS Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with 7+ years of biotechnology and/or cell therapy experience
• High School diploma with 11+ years biotechnology and/or cell therapy experience

Preferred Qualifications:

• Industry experience in process validation, technology transfer and/or biopharmaceutical cGMP manufacturing operations in the biologics or life sciences field
• Expertise in Process Validation Stage 2 and 3 related to PPQ and CPV
• Cell and gene therapy expertise is preferred
• Cell culture or aseptic processing expertise is a plus
• Equipment qualification expertise in a cGMP environment (IQ, OQ, PQ) is a plus
• Knowledge of data management tools and statistical process as well statistical analysis using JMP or Minitab is a plus
• Creative and thoughtful problem-solving skills
• Ability to adapt and work autonomously in a changing environment with critical timelines
• Global, proactive, solution oriented and self-starter mindset
• Excellent interpersonal communication skills
• Support and work in cross-functional, collaborative, and inclusive teams