MES IT Application Specialist *PC 1542

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 and 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; Or a combination of education and experience.
• 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).
• Experience with inbound and outbound application interfaces and messaging brokers, ideally with NATS and SAP/CPI, is of advantage.
• 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.

Skills and Abilities:

• 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.

Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 50 pounds (dual lift). Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail. Must be able to travel routinely by car and plane.

Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.

The hiring range for this position is expected to fall between $85,500-100,600/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

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.

Miltenyi Biotec, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.