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Resilience

Biologics and sterile injectables CDMO

Digital Manufacturing Systems Engineer - Automated Material Handling Systems

Enterprise ApplicationsConfirmed live in the last 24 hours
Full-timeWest Chester Township, OH, USAIn-person

About the Job

Requirements

  • Experience with Warehouse Management Systems (WMS) and Warehouse Execution Systems (WES).
  • Working knowledge of SQL queries.
  • Demonstrated ability to handle multiple competing priorities and projects in a fast-paced environment, with a proven track record of delivering results on large cross-functional projects.
  • Ability to collaborate across internal teams and external vendors and suppliers.
  • Ability to adapt to challenges and overcome obstacles through stakeholder alignment, communication, and strategic execution.

Responsibilities

  • Analyze, advocate for, and implement Continuous Improvement projects to improve operational performance of Digital platforms associated with the AMHS, including AMRs, ASRSs, and WES.
  • Implement changes to Digital platforms associated with the AMHS as required for capacity increases, site expansions, and other CapEx projects.
  • For CapEx and Continuous Improvement projects, work with Quality and Validation teams to generate, implement, and execute lifecycle documentation as applicable, including requirements, functional specifications, design and configuration specifications, Standard Operating Procedures (SOPs), Work Instructions (WIs), and validation protocols (IQ/OQ/PQ), using the Veeva Validation Management eVLMS and Veeva Vault QMS.
  • In accordance with SOPs and WIs, perform changes using Change Controls in Veeva Vault QMS and ServiceNow, and record support activities in ServiceNow and SAP Plant Maintenance Notifications and Work Orders as applicable.
  • Leverage AI to develop support and troubleshooting tools for Digital platforms associated with the AMHS.
  • Provision user access to Digital platforms associated with the AMHS.
  • Perform annual user access and system audit trail reviews for Digital platforms associated with the AMHS.
  • Coordinate and/or perform patching and SSL certificate renewals for Digital platforms associated with the AMHS.
  • Develop and maintain a Library of Knowledge Base Articles in ServiceNow for Digital platforms associated with the AMHS.
  • Provide Monday-Friday daytime support and rotational on-call support during evenings, weekends, and holidays.
  • Build relationships and collaborate with Automation, Facilities Engineering and Maintenance, ERP/Information Systems, Infrastructure/IT, Manufacturing, Manufacturing Sciences & Technology, Material Handling/Warehouse, Project Management, Quality, Supply Chain/Planning, Training and Development, and Validation organizations and vendor teams.

Desired Qualifications

  • Experience working in a cGMP environment.
  • Bachelor of Science degree in an Engineering discipline.
  • Experience with Automated Material Handling Systems (AMHS), including Autonomous Mobile Robots (AMR) and Automated Storage and Retrieval Systems (ASRS), including automated pallet chain/roller conveyors, cranes, and shuttle cars.
  • Experience with the following modules/submodules in SAP ECC: Inventory Management (MM-IM), Plant Maintenance (PM), and Warehouse Management (WM).
  • Experience with IDoc display and monitoring transactions in SAP ECC.
  • Experience with an Oracle database running on Linux OS.
  • Familiarity with SSL certificates for system-to-system authentication.
  • Experience performing Impact Assessments and owning Change Controls throughout the entire workflow, from Initiation through Closure, using the Veeva Vault QMS Change Control workflow/data object.
  • Experience authoring and executing Installation Qualifications (IQs), Operational Qualifications (OQs), and Performance Qualifications (PQs) in the Veeva Validation Management application.

About the Company

Resilience

Biologics and sterile injectables CDMO

Resilience is a North American CDMO focused on biologics and sterile drug products. It provides end-to-end services from development through commercial production, including biologics development and drug substance manufacturing, aseptic fill/finish, device assembly, packaging, logistics, regulatory support, and tech transfer, all coordinated via a stage-gate process and a digital quality management system. It differentiates itself with North American-based, integrated biologics and sterile capabilities, a focus on sterile injectables and device assembly, and recent expansion into injectable pen devices for diabetes and obesity medicines. Its goal is to broaden access to complex medicines while protecting North American biopharma supply chains with dependable capacity and strong regulatory support from clinical development to commercial scale.

Company size
1,001-5,000
Company stage
Growth Equity (Venture Capital)
Total funding
$3.2B
Headquarters
Blue Ash, OH
Founded
2020

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