Lead Engineer - MES Opcenter

Overview

Remote
On Site
Full Time

Skills

Manufacturing Execution System
VMware Infrastructure
VI
Pharmaceutics
MES
Systems Design
Conflict Resolution
Problem Solving
Leadership
Project Implementation
Mentorship
Regulatory Compliance
HIPAA
Sarbanes-Oxley
Software Development Methodology
Supply Chain Management
Manufacturing
Medical Devices
Siemens
Application Development
Project Management
GxP
Computerized System Validation
Communication
Computer Networking
Management
Interface Design
RESTful
Vendor Management

Job Details

Job Description:
The Lead Engineer will lead a team of technical resources to design, develop, configure, and test MES (Manufacturing Execution Systems) solutions. They will be directly responsible for leading resources contracted vi third-party and through other Pharmaceutical organizations to develop & deploy MES application software to Medical Device manufacturing sites globally.
Responsibilities:
  • Act as subject matter expert on system design and architecture.
  • Solutioning and designing new functionality.
  • Provide innovative ways of problem solving and implementing system improvements.
  • Look for out-of-the-box solutions to new requirements or to deprecate prior customizations.
  • Be the single point of contact for the technical deliverables of the project and know the status, risks, and issues always, and coordinate/provide reports outs & updates to leadership teams and stakeholders.
  • Application development oversight, ensuring quality and timely delivery of project execution and completion.
  • Hands-on application development on occasion to resolve issues and lead by example.
  • Work with other stakeholders and team members to identify, manage, and resolve risks.
  • Escalate and track cross-squad dependencies and impediments before they affect project deliverables, timeline, or cost.
  • Lead a team of internal and external professionals, geographically dispersed.
  • Mentor, coach, and teach other technical team members on best practices/principles.
  • Ensure IT compliance (WICO, HIPAA, GXP, 21 CFR Part 11, Records
  • Management, SOX, SDLC, CSV) requirements in all activities and solutions are delivered.
Requirements:
  • 5 years' experience supporting Supply Chain/Manufacturing Systems required.
  • Experience in regulated manufacturing required (medical device preferred).
  • Experience in a Siemens OpsCenter/Camsteary technical role (hands-on) required.
  • Experience in application development and support required.
  • Experience in project management and delivery with benefits delivered as committed and required.
  • Experience in GxP systems, Computer System Validation, and a consistent track record in the support of FDA-regulated systems and business is required.
  • Strong interpersonal skills required. Excellent communication, networking, and influencing skills, including the ability to manage across all management and organizational levels required.
  • Ability to manage and drive multiple projects simultaneously is required.
  • Experience with application interface design and development (Rest API, for example) preferred.
  • Ability to work autonomously as an empowered leader.
  • Vendor management experience preferred.
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