Manager, Manufacturing Systems Engineer I, MS&T MSEO

Celgene-posted 4 months ago
$106,810 - $129,430/Yr
Full-time • Mid Level
Hybrid • Summit, NJ
Merchant Wholesalers, Nondurable Goods
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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. Shift Available: Monday - Friday, Hybrid Day Shift, 9 a.m. - 5 p.m.

  • Work on and contribute to the Summit Cell Therapy Facility Automation Systems (Process automation), the data collection (OSI PI) and analytics deliverables.
  • Partner 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.
  • Deliver the requirements for the Process Automation Systems (DeltaV) EMES infrastructure as well as the Unit operations within the Process automation system.
  • 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.
  • 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.
  • Ensure 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 integrate 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.).
  • Bachelor's degree at minimum required in Engineering, Biological/Life Sciences, Chemistry, Biochemistry or related field.
  • 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).
  • 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.
  • 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.
  • Medical, pharmacy, dental and vision care.
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
  • Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
  • Other perks like tuition reimbursement and a recognition program.
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