MES Senior Systems Administrator

Peachtree, GA - USA

Monthly Salary: Not Disclosed

Posted on: 9 hours ago

Vacancies: 1 Vacancy

Job Summary

Purpose of the Role:
Serve as the primary contact between production/operations and IT for the Manufacturing Execution System (MES) ensuring stable daily operation effective use by end users and continuous improvement of system-supported processes.

Independently develop end-to-end highly integrated IT processes to comprehensively improve business operations while ensuring cross-plant standardization including performing a gatekeeper function.
Take a leading role in the implementation configuration and support of IT applications in the relevant functional area (especially ERP/MES RPA etc.).
Actively and continuously analyze end-to-end business processes and identify optimization potential through appropriate IT solutions (e.g. SAP Industry 4.0 applications).
Independently plan and implement organizational system adjustments in close cooperation with the specialist departments and central IT departments.
Independently execute necessary adjustments (customizing and migrations) during live operation ensuring maximum cross-plant synergies and compliance with the medical industrys validation and documentation requirements.
Assume the role of key user/process expert within project teams actively managing local IT projects and changes.
Independently plan and conduct employee training sessions and workshops and advise users on IT-related problems to maximize the utilization and efficiency of IT systems.
Gatekeeper Function: Serve as the interface to central IT departments; align local IT initiatives with division-wide IT standards and applications; coordinate and request developments/customizing in central IT systems via defined platforms (e.g. Change Advisory Board).

Functional KPIs

Ensure reliable operation of implemented IT systems.
Achieve defined project goals in the role of Change Owner/Project Manager.
Ensure timely implementation of corrective or improvement measures in IT systems.

Qualifications :

Degree or strong experience in engineering life sciences or a related technical discipline preferably within medical device or other FDAregulated manufacturing.
Solid handson experience in device manufacturing operations process engineering or quality with very good understanding of GMP ISO 13485 and device history / batch documentation.
Practical experience with an MES or EBR platform in a regulated environment including working with electronic records audit trails and esignatures.
Good understanding of 21 CFR Part 11 concepts (electronic records electronic signatures audit trail access control) and how they apply to MES.
Strong communication and training skills able to work crossfunctionally with production QA/RA engineering and IT.
Structured detailoriented and comfortable with documentation validation evidence and supporting audits.

Additional Information :

Why Join Us:

Be part of a company that values your skills and ideas
Work in an environment where quality truly matters
Join a team that supports each other and grows together
Contribute to products that have global impact

Join us and be part of a forward-thinking team dedicated to innovation and excellence. Together we will drive digital transformation and achieve remarkable results.

Remote Work :

Employment Type :

Full-time

Purpose of the Role:Serve as the primary contact between production/operations and IT for the Manufacturing Execution System (MES) ensuring stable daily operation effective use by end users and continuous improvement of system-supported processes.Independently develop end-to-end highly integrated I...

Independently develop end-to-end highly integrated IT processes to comprehensively improve business operations while ensuring cross-plant standardization including performing a gatekeeper function.
Take a leading role in the implementation configuration and support of IT applications in the relevant functional area (especially ERP/MES RPA etc.).
Actively and continuously analyze end-to-end business processes and identify optimization potential through appropriate IT solutions (e.g. SAP Industry 4.0 applications).
Independently plan and implement organizational system adjustments in close cooperation with the specialist departments and central IT departments.
Independently execute necessary adjustments (customizing and migrations) during live operation ensuring maximum cross-plant synergies and compliance with the medical industrys validation and documentation requirements.
Assume the role of key user/process expert within project teams actively managing local IT projects and changes.
Independently plan and conduct employee training sessions and workshops and advise users on IT-related problems to maximize the utilization and efficiency of IT systems.
Gatekeeper Function: Serve as the interface to central IT departments; align local IT initiatives with division-wide IT standards and applications; coordinate and request developments/customizing in central IT systems via defined platforms (e.g. Change Advisory Board).

Functional KPIs

Ensure reliable operation of implemented IT systems.
Achieve defined project goals in the role of Change Owner/Project Manager.
Ensure timely implementation of corrective or improvement measures in IT systems.

Qualifications :

Degree or strong experience in engineering life sciences or a related technical discipline preferably within medical device or other FDAregulated manufacturing.
Solid handson experience in device manufacturing operations process engineering or quality with very good understanding of GMP ISO 13485 and device history / batch documentation.
Practical experience with an MES or EBR platform in a regulated environment including working with electronic records audit trails and esignatures.
Good understanding of 21 CFR Part 11 concepts (electronic records electronic signatures audit trail access control) and how they apply to MES.
Strong communication and training skills able to work crossfunctionally with production QA/RA engineering and IT.
Structured detailoriented and comfortable with documentation validation evidence and supporting audits.

Additional Information :

Why Join Us:

Be part of a company that values your skills and ideas
Work in an environment where quality truly matters
Join a team that supports each other and grows together
Contribute to products that have global impact

Join us and be part of a forward-thinking team dedicated to innovation and excellence. Together we will drive digital transformation and achieve remarkable results.

Remote Work :

Employment Type :

Full-time

Key Skills

Computer Science
Active Directory
Computer information Technology
PowerShell
OS
Windows
Database
SCCM
Linux
SAN
Troubleshoot
Backup
Setup
Technical Support
UNIX

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About Company

Gerresheimer

Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end pr ... View more

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