Sr. Specialist, Manufacturing Systems Engineer II, MS&T MSEO

Role Summary

The MS&T Manufacturing Systems Engineering and Operations - Manufacturing Systems Engineer II is responsible for supporting the solution intake and design, delivery, operational support, continuous improvement, change management, and lifecycle for the site manufacturing execution system (MES) and associated boundary systems used in the production of personalized cell therapy products for both global clinical trials and commercial supply. The incumbent must be self-directed, goal-oriented, flexible, able to work efficiently across multiple projects, enthusiastic, and innovative, with a good understanding of good manufacturing practices and technologies to support the needs of the Site Manufacturing Teams. Works under the guidance of lead team members.

Responsibilities

• Provide technical direction and expertise across Site teams (Manufacturing, Quality, Supply Chain, Shared Services, etc.) to support and improve capacity, quality, and cost or to establish root cause.
• Work closely with end users/process owners and subject matter experts to maintain service level expectations across all functions and site systems.
• Provide on-the-floor or remote process support for ongoing manufacturing activities when needed.
• Participate in delivering critical improvements across the manufacturing network through digital technology (e.g., EBR) updates and technical insight.
• Provide MES product impact assessments to support change management, investigations, and product release.
• Develop inputs into electronic batch record/process automation technologies to advance digital manufacturing strategy.
• Lead or 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 per business requirements and applicable procedures throughout the recipes and MES system lifecycle from design to implementation.
• Support lifecycle management project implementation at a site level to accomplish drug product harmonization across sites and evolve the process.
• Translate business requirements into functional and design specifications that are compliant, efficient, and effective.
• Participate in project teams to help prepare 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 goals.
• Interface with Manufacturing groups, Quality groups, Supply Chain, IT, MSAT groups, etc. and serve as applicable Manufacturing System Business Owner.
• Perform process monitoring initiatives, including but not limited to developing and collecting data, analyzing and optimizing the end-to-end process, and anticipating and permanently resolving issues that may arise during production.
• Continuously integrates with the business to understand current business processes and to provide technology guidance that enables and supports Digital Plant plans and strategies.
• Stay current with industry trends and standards (e.g., PDA, ISPE) and participate in best practice forums consistent with function responsibilities.
• Perform revisions of technical documentation content (e.g., investigations, changes, SOPs, and process-related).
• Support Technical Product Team, Validation, Development, Operations, QA, and Regulatory in the area of expertise.
• Participate in routine plant operating meetings (i.e., Tiers, town halls, MSAT Extended Staff, etc.).
• Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
• Support health authority and internal inspections.

Knowledge & Skills

• Critical reasoning and decision-making skills.
• Ability to think strategically and translate strategy into actions.
• Ability to work independently and in cross-functional teams.
• Advanced technical document writing.
• Advanced time management skills, including prioritizing and managing expectations in a fast-paced working environment.
• Must have excellent organization skills and ability to manage multiple tasks.
• Operate effectively and with moderate supervision within a team or independently, performing projects and related duties.
• Intermediate knowledge of MS Office Applications.
• Working knowledge of Electronic Batch Records (EBR), Review by Exception (RBE), and MES Recipe object lifecycle management preferred.
• Experience with HP ALM, Electronic Document Management Systems, and Change Management Systems preferred.
• Knowledge of cGMPs and multi-national biopharmaceutical regulations. Cell therapy experience is preferred.
• Knowledge of the relationship between manufacturing processes, ERP, and MES preferred.
• Experience with single-use technologies, closed systems, and cold chain/cryogenic technologies, Packaging, Shop floor quality, batch review, or disposition is preferred.
• Possess strong verbal and written communication skills.
• Ability to communicate honestly, transparently, and effectively with peers, department management, and cross-functionally.
• Hands-on experience preferred with CAR T or biopharmaceutical manufacturing and Quality Control.
• Proven delivery of complex investigation reports preferred.
• Ability to train and mentor junior associates to foster and develop their expertise. ability to coach, develop, delegate, and motivate others.

Education

• Bachelor's degree at minimum required in Engineering, Biological/Life Sciences, Chemistry, Biochemistry or related field. An equivalent combination of education and work experience to be considered. Advanced degree preferred.
• A minimum of 3 years of relevant work experience in cell therapy working in an EMES system (or equivalent systems such as Syncade, PasX).
• A minimum of 3 years of EMES system (or equivalent systems) validation (backend validation, UAT, etc.).
• Experience with MES, ERP, LIMS, or other manufacturing boundary systems and technologies.
• Understanding cell culture, cryopreservation, purification, aseptic processing or lab technique, Packaging, Shop floor quality, batch review, or disposition.

Additional Requirements

• Preferred: Experience with BMSDocs or similar change management systems.