Manager, Manufacturing Systems Engineer I, MS&T MSEO

Role Summary

The Manager, Manufacturing Systems Engineer I, MS&T MSEO will support the successful implementation and operation of Process Automation systems integrated with EMES through interaction with internal team members, peer and higher-level customers as well as external service providers. Manufacturing Systems Automation Engineers primarily work with local (site) Business Process Owners, Global MS&T, Global IT, Cell Therapy Network subject matter experts, MSEO Operations support, Site IT, and resources supporting boundary systems to perform role responsibilities. The individual is responsible for development of and adherence to system governance procedures and 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.

Responsibilities

• Will work on and contribute to the Summit Cell Therapy Facility Automation Systems (Process automation), the data collection (OSI PI) and analytics deliverables.
• Partnering with Mfg. Operations & IT colleagues (Manufacturing, MS&T, Quality, Site Engineering), Enterprise teams (Global MS&T, Enterprise MES), Enterprise Business teams and local system Digital Capability Managers to deliver the requirements for the Summit Cell therapy facility for the following:
  • Delivering the requirements for the Process Automation Systems (DeltaV) EMES infrastructure as well as the Unit operations within the Process automation system.
  • Integration needs with the Manufacturing Execution System (Syncade) & Data Historian (OSI PI)
• Help set the PAS priorities for the Summit CTF and work the delivery of these priorities.
• Work with the technical teams to develop the requirements, code and test the deliverables and drive execution of system testing at the site level.
• Network and work with other cell therapy PAS members to proactively identify issues with cell therapy-based requirements and drive the resolutions.
• Work with enterprise PAS team and SMEs to develop PAS standards, philosophy, design approach and SOPs for Summit CTF.
• Will drive and support the resolution of critical PAS issues.
• 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.
• Participate in delivering critical improvements across the manufacturing network through digital technology (e.g., EBR) updates and technical insight.
• 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.
• Support the change initiatives and the implementation of process improvement initiatives.
• Continuously integrates with the business to understand current business processes and to provide technology guidance that enables and supports Digital Plant plans and strategies.
• 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

Skills

• Demonstrated expertise in Process Automation Systems, specifically DeltaV, and data collection (i.e., OSI PI).
• Expert understanding of S88, S95 and batch processing operations required.
• Understanding of engineering documentation such as P&IDs, FS/SCRs, process flow diagrams, and standard operating procedures.
• Ability to troubleshoot control systems from the field element up through operator interfaces and databases.
• Experience with control system networking technologies, PC networking technology and virtualization required.
• Experience working with SQL, Server, Oracle, SAP, or other relational databases required.
• Experience with single-use technologies, closed systems, and cold chain/cryogenic technologies, Packaging, Shop floor quality, batch review, or disposition is preferred.
• 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.
• Excellent communication skills including oral, written and formal presentations.
• Ability to communicate honestly, transparently, and effectively with peers, department management, and cross-functionally.
• Strong interpersonal skills and the ability to work in a team environment.
• Operate effectively and with moderate supervision within a team or independently, performing projects and related duties.
• Ability to work effectively in a fast-paced multi-tasking environment.
• Must have excellent organization skills and ability to manage multiple tasks.
• Ability to work in a diverse work environment, manage multiple priorities, and be self-directed.
• Critical reasoning and decision-making skills.
• Ability to think strategically and translate strategy into actions.
• 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.

Additional Requirements

• Minimum 5 years' relevant pharmaceutical industry experience.
• Minimum of 3 years' experience with Emerson DeltaV.
• Minimum of 3 years' experience with OSI Pi.
• Must have understanding of supply chain, manufacturing domains and supporting technology including manufacturing and supply chain ERP systems (e.g., Oracle, SAP).
• Understanding cell culture, cryopreservation, purification, aseptic processing or lab technique, Packaging, Shop floor quality, batch review, or disposition preferred but not required.