Lead Engineer - MES Opcenter

Overview

Remote
Depends on Experience
Full Time

Skills

Application Development
MES
GxP
HIPAA
Siemens
Supply Chain Management
Vendor Management
Systems Design
Records Management
Sarbanes-Oxley

Job Details

Lead Engineer MES Opcenter - 45665-1

Max Supplier

Location: 100% remote

Client Name: Johnson & Johnson

JD:

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 responsibility for leading resources contracted via a third-party and through other J&J organizations to develop & deploy MES application software to Medical Device manufacturing sites globally.

The Lead Engineer will be responsible for:

  • 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 at all times and coordinate/provide report 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.

Qualifications:

  • 5 years experience supporting Supply Chain/Manufacturing Systems required.
  • Experience in regulated manufacturing required (medical device preferred).
  • Experience in a Siemens Opcenter/Camstar technical role (hands on) required.
  • Experience in application development and support required.
  • Experience in project management and delivery with benefits delivered as committed required.
  • Experience in GxP systems, Computer System Validation, and consistent track record in the support of FDA regulated systems and business 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 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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