Manufacturing Systems Administrator

Cirtec Services GmbH; Lowell (MA); Presencial; USD 70.000 - 85.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Training and career development

Healthcare and well-being programs

Paid Time Off and 401(k) with company

Descripción de la vacante

Cirtec Medical Corporation seeks a Manufacturing Systems Administrator to manage MasterControl Mx, MES, and eDHR in a regulated manufacturing environment. You will ensure data integrity, regulatory compliance, and continuous improvement while partnering with Engineering, Quality, and Production teams.

The role emphasizes system validation, updates, and training material creation, with on-site responsibilities and a focus on cGMP and ISO standards.

Formación

• Bachelor's or master's degree in Systems Engineering, Computer Engineering, Industrial Engineering, or a related engineering field.
• Experience in systems administration within a regulated manufacturing environment, such as medical devices, pharmaceuticals, or biotechnology.
• Strong knowledge of MasterControl, specifically the Manufacturing Excellence (Mx) Suite.
• Experience with MES/eDHR systems and API-based system integrations.
• Experience working with integrated enterprise systems such as ERP, EDMS, or QMS.
• GxP/GMP experience strongly preferred.
• Strong technical troubleshooting, analytical, organizational, and communication skills.
• Ability to manage multiple projects and priorities simultaneously.
• Strong English reading, writing, and verbal communication skills.
• On-site position; not remote.

Responsabilidades

• Serve as the primary administrator and technical expert for MasterControl Mx, MES, and eDHR.
• Manage system access, user roles, permissions, monitoring, maintenance, and troubleshooting.
• Configure and optimize workflows, electronic forms, system settings, and manufacturing processes.
• Support system validation, software updates, new modules, integrations, and system enhancements.
• Partner with Engineering, Quality, and Production teams to implement automation and process improvements.
• Provide end-user support and develop system training materials and documentation.
• Ensure employees follow applicable SOPs and system requirements.
• Maintain compliance with cGMP, FDA, ISO, change-control, and data-integrity requirements.
• Support audits by providing system documentation, reports, and evidence.
• Develop reports and dashboards to monitor manufacturing quality, efficiency, and KPIs.

Conocimientos

Regulated manufacturing

System administration

GxP experience

SOP compliance

Documentation skills

Educación

Engineering degree (BSc/MSc)

Herramientas

MasterControl Mx

API Integrations

Descripción del empleo

Description

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Manufacturing Systems Administrator manages, supports, and optimizes the company's Manufacturing Execution System (MES), primarily MasterControl Manufacturing Excellence (Mx). This role ensures system reliability, data integrity, regulatory compliance, and continuous improvement within a regulated manufacturing environment.

Key Responsibilities:

• Serves as the primary administrator and technical expert for MasterControl Mx, MES, and electronic Device History Records (eDHR).
• Manages system access, user roles, permissions, monitoring, maintenance, and troubleshooting.
• Configures and optimizes workflows, electronic forms, system settings, and manufacturing processes.
• Supports system validation, software updates, new modules, integrations, and system enhancements.
• Partners with Engineering, Quality, and Production teams to implement automation and process improvements.
• Provides end-user support and develops system training materials and documentation.
• Ensures employees are properly trained and follow applicable SOPs and system requirements.
• Maintains compliance with cGMP, FDA, ISO, change-control, and data-integrity requirements.
• Supports internal and external audits by providing system documentation, reports, and evidence.
• Develops reports and dashboards to monitor manufacturing quality, efficiency, and KPIs.

Must Have:

• Bachelor's or master's degree in Systems Engineering, Computer Engineering, Industrial Engineering, or a related engineering field.
• Experience in systems administration within a regulated manufacturing environment, such as medical devices, pharmaceuticals, or biotechnology.
• Strong knowledge of MasterControl, specifically the Manufacturing Excellence (Mx) Suite.
• Experience with MES/eDHR systems and API-based system integrations.
• Experience working with integrated enterprise systems such as ERP, EDMS, or QMS.
• GxP/GMP experience strongly preferred.
• Strong technical troubleshooting, analytical, organizational, and communication skills.
• Ability to manage multiple projects and priorities simultaneously.
• Strong English reading, writing, and verbal communication skills.
• On-site position; not remote.

Salary Range:

$70K - $85K

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.