Specialist, Engineer I

This role is responsible for supporting the production of personalized cell therapy products for both global clinical trials and commercial supply. Potential areas of responsibility include (a) providing day-to-day manufacturing support, (b) leading manufacturing investigations pertaining to the process control strategy and associated elements, (c) managing multidisciplinary projects aimed at improving the process, and (d) developing input into process automation systems to deliver advances in manufacturing strategy. These areas include creation/revision of engineering documentation and management of external resources (e.g. engineers and/or scientists) required to support the production of personalized cell therapy products. Cross-functional collaboration with SMEs from the Development Group, Manufacturing Group, Supply Chain Group, and Quality Group is essential to ensuring technical support is delivered to a rapidly growing CAR-T manufacturing organization.

Responsibilities include, but are not limited to, the following:

• Provide on the floor process support for ongoing manufacturing activities when needed.
• Lead deviation investigations utilizing root cause analysis tools.
• Develop inputs into electronic batch record/process automation technologies to advance digital manufacturing strategy
• Assist in designing, testing, and maintaining Electronic Batch Records and related manufacturing data, including, but not limited to specifications, process parameters, recipes, routings, formulas, process instructions, and process variables.
• Ensuring Recipes/MES are configured for intended use in accordance with business requirements and applicable procedures throughout the recipes and MES system lifecycle from design to implementation.
• Translate business requirements into functional and design specifications which is compliant, efficient, and effective.
• Participate on project teams to help prepare project schedules, execute technical projects and develop presentations to disseminate results to project stakeholders and senior management.
• Support the change initiatives and the implementation of process improvement initiatives.
• Foster strong inter-team relationships to achieve common project goals.
• Interface with operations and serve as process SME
• Support monitoring, analyzing, and optimizing the end-to-end process and anticipate and permanently resolve issues that may arise during production.
• Execute test plans and other risk mitigation exercises as part of investigations (e.g. Root cause analysis and CAPAs).
• Organize, record and maintain experimental data.
• Stay current with industry trends and standards (e.g. PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
• Assist with revisions of the content of technical documentation (e.g. investigations, changes, SOPs and batch records).
• Interact with other teams including Validation, Development, Operations, QA and Regulatory.
• Participate in routine plant operating meetings.
• Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Support health authority inspections
• Ability to set priorities, manage timelines and effectively react/manage changing priorities.
• Ability to work with management (global and site) and support corporate and departmental goals.
• Ability to communicate honestly, transparently, and effectively with peers, department management and cross functional peers.
• Hands on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control. Proven delivery of complex investigation reports.

Ability to train and mentor junior associates to foster and develop their expertise.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy experience is a major plus.
• Knowledge of the relationship between manufacturing processes, ERP, and MES a major plus
• Must have excellent organization skills and ability to handle multiple tasks
• Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies.
• Possess strong verbal/written communication skills.
• Ability to think strategically and to translate strategy into actions.

Education and Experience:

• Bachelors Degree required (science or engineering is preferred) with 3+ years of relevant experience.