Lead Engineer - MES Opcenter - Katalyst Healthcares and Life Sciences : 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.