Offer summary

Qualifications:

5 years of experience in Supply Chain/Manufacturing Systems, preferably in regulated manufacturing., Hands-on experience in a Siemens Opcenter/Camstar technical role is required., Strong interpersonal and communication skills are essential for managing diverse teams and stakeholders., Experience in project management, GxP systems, and application development is necessary..

Key responsibilities:

Lead a team to design, develop, configure, and test MES solutions for Medical Device manufacturing.

Act as the subject matter expert on system design and architecture, providing innovative problem-solving solutions.

Serve as the single point of contact for technical deliverables, coordinating updates and reports to leadership.

Mentor and coach team members on best practices while ensuring compliance with IT regulations.

Job description

Role: Lead Engineer – MES Opcenter

Location: Remote

Type : Contract

JD:

Lead Engineer – MES OpCenter

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 Pharmaceutical 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.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.

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