Manufacturing Systems Administrator

About us:
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 Systems (MES), specifically MasterControl's Manufacturing Excellence (Mx) system. This role works to streamline manufacturing operations, enforce compliance, and ensure data integrity within a highly regulated production environment. A strong background in systems administration and experience in life sciences or manufacturing are essential for success.

Key Responsibilities:
System administration

• Serve as the primary system administrator and technical expert for the MasterControl Mx system and its associated modules, including Manufacturing Execution System (MES) and Electronic Device History Records (eDHR).
• Perform routine system monitoring, maintenance, and user management (e.g., configuring user access, roles, and permissions).
• Troubleshoot and resolve technical issues reported by manufacturing end-users, escalating problems to MasterControl support when necessary.
• Support system validation activities, including creating and executing validation protocols and documentation.

Configuration and optimization

• Configure and optimize system workflows, electronic forms, and settings to align with business requirements and process improvements.
• Implement software updates, new modules, and system enhancements to improve functionality and maintain compliance.
• Collaborate with engineering, quality assurance, and production teams to identify and implement new automation and process improvements using the Mx platform.

Support and training

• Develop, deliver, and maintain training materials and documentation for users at all levels.
• Act as the main point of contact for end-user support, addressing system and process-related questions.
• Ensure all production personnel are properly trained and follow standard operating procedures (SOPs) within the system.

Compliance and reporting

• Maintain the system in a compliant state according to industry regulations such as Current Good Manufacturing Practices (cGMP), FDA guidelines, and ISO standards.
• Assist in internal and external audits by providing documentation, reports, and system evidence as requested.
• Develop custom reports and dashboards to track key performance indicators (KPIs) related to manufacturing quality and efficiency.
• Enforce corporate policies and procedures for system use, change control, and data integrity.

Must Have:

• Proven experience in a system administration role within a regulated manufacturing environment, such as pharmaceuticals, medical devices, or biotech.
• Experience in a GxP environment (e.g., GMP) is highly preferred.
• Excellent technical troubleshooting, problem-solving, and communication skills.
• Strong organizational and time-management skills, with the ability to manage multiple projects simultaneously.
• Strong English skills – Reading, writing, and verbal communication

Good to have:

• Strong understanding of MasterControl's platform, with specific knowledge of the Manufacturing Excellence (Mx) suite.
• Experience with API based integrations to support, optimize and troubleshoot integrations between systems.
• Experience with other integrated enterprise systems such as ERP or EDMS/QMS.
• Bachelor's degree
• Active US Travel Visa

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.