Specialist, Engineer , MSAT Process Engineering - Summit West NJ

Job Description

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Unless specifically stated otherwise, this role is On‑Site at the location detailed in the job post.

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) supporting lifecycle management of MBRs. These areas can include creation/revision of documentation (i.e. SOP, validation documentation, technical reports, etc.)

required to support the production of personalized cell therapy products. Cross‑functional collaboration with SMEs from the Manufacturing Group, Supply Chain Group, and Quality Group is essential to ensuring technical support is delivered to a rapidly growing CAR‑T manufacturing organization.

Monday - Friday, Hybrid Day Shift, 9 a.m.

- 5 p.m.

• Provide on‑the‑floor or remote process support for ongoing manufacturing activities when needed.
• Support deviation investigations utilizing root cause analysis tools.
• Lead product impact assessments to support investigations.
• Become a process SME and interface with operations and QA Shop Floor.
• Support process monitoring initiatives, including collecting data, optimizing the end‑to‑end process, and permanently resolving issues during production.
• Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Support health authority and/or internal inspections.
• Assist in maintaining Manufacturing Batch Records (MBRs) and/or Electronic Batch Records, including specifications, process parameters, process instructions, and process variables.
• Organize, record, and maintain experimental data.
• Assist with revisions of technical documentation (e.g., change actions, SOPs, and batch records).
• Support lifecycle management project implementation at a site level.
• Participate in project teams to help prepare project schedules, execute technical projects, and develop presentations to disseminate results to stakeholders and senior management.
• Support change initiatives and the implementation of process improvement initiatives.
• Foster strong inter‑team relationships to achieve common project goals.
• Interface with other teams, including but not limited to Technical Product Team, Validation, Development, Operations, QA, and Regulatory.
• Participate in routine plant operating meetings (i.e., Tiers, Townhalls, MSAT Extended Staff, etc.).
• Ability to communicate honestly, transparently, and effectively with peers, department management, and cross‑functional peers.
• Stay current with industry trends and standards (e.g., PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
• 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.

466539

Associates

Analyst

Knowledge &

Skills:

• 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.
• Must have excellent organizational 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.

• Bachelor’s Degree required…