MES IT Application Specialist PC 1542

Miltenyi Biotec • Gaithersburg, MD

29d

About The Position

Your Role: The IT Application Specialist will support and maintain internally developed MES-LIMS solutions built on Linux, PostgreSQL, and Kubernetes. This role involves global service management, troubleshooting, and optimization of IT processes for a proprietary MES-LIMS system used in the production and quality control of cell and gene therapy products. They will collaborate with international stakeholders, support requirement analysis, ensure system reliability, manage infrastructure and interfaces, and contribute to validation and documentation efforts. This is a unique opportunity to work in a dynamic, fast-growing biotech environment focused on treating serious diseases like cancer and Parkinson’s. Essential Duties & Responsibilities: Ensure ongoing operations by performing all tasks within the scope of application support management according to our standards (i.e. ITIL) Maintain the application/application service environment. Participate in projects/applications for transition to operation (service transition). Plan and execute integration test, performance tests, regression tests. Maintain security and integrity controls. Maintain operations handbook and solution documentation. Formulate and conduct training sessions and teaching materials for expanding systems support knowledge including global subsidiary training remotely and onsite. Set up and maintain a list of (key) users and provide on-call technical support for these users. Design and produce standardized and customized reports. Lead cross-functional teams across departments and global locations to address business or systems issues.

Requirements

• Bachelor’s degree in computer science or engineering, e.g., mechanical engineering, production or process engineering, biotechnology, or a comparable field with a strong IT affinity
• At least 3 years of professional experience in application operations, application support, or consulting, especially with MES and high-availability environment.
• You have excellent process knowledge in a manufacturing environment, ideally with a clinical background.
• Experience in managing applications on various operating system platforms (Linux, Windows Server), databases (PostgreSQL and MSSQL), and containerization (Kubernetes).
• Familiarity with common programming and scripting languages (e.g., C, Java, JavaScript, Python, VBA).
• Deep understanding of agile working methods and IT processes based on ITIL and DevOps and can draw on success in the stable operation of IT applications.
• Experience in computer-aided system validation (CSV) in relation to FDA CFR Part11 regulations and ISO13485 quality standards.
• Focus on Operational Excellence, problem solving, decision making, and quality deliverables.
• Experience in project collaboration, application design, implementation, and testing.
• Ability to manage projects in high-compliance environments (GMP, FDA-regulated)
• Strong cross-cultural collaboration skills; ability to lead diverse, distributed teams effectively.
• Ability to create and deliver clear training materials and communications to effectively explain projects, systems, and processes to diverse stakeholders.
• Must speak English fluently, German a plus.

Nice To Haves

• Experience with inbound and outbound application interfaces and messaging brokers, ideally with NATS and SAP/CPI, is of advantage.
• Must speak English fluently, German a plus.

Responsibilities

• Ensure ongoing operations by performing all tasks within the scope of application support management according to our standards (i.e. ITIL)
• Maintain the application/application service environment.
• Participate in projects/applications for transition to operation (service transition).
• Plan and execute integration test, performance tests, regression tests.
• Maintain security and integrity controls.
• Maintain operations handbook and solution documentation.
• Formulate and conduct training sessions and teaching materials for expanding systems support knowledge including global subsidiary training remotely and onsite.
• Set up and maintain a list of (key) users and provide on-call technical support for these users.
• Design and produce standardized and customized reports.
• Lead cross-functional teams across departments and global locations to address business or systems issues.

Benefits

• In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan.
• All benefits are subject to eligibility requirements.
• Certain positions may also be eligible for additional compensation such as bonuses or commissions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level