Technical Implementation Specialist
Fresenius Kabi USA
Summary
The Technical Implementation Specialist is responsible for the implementation and technical support of the Cell & Gene Therapy (CGT) Technologies portfolio's software application at customer sites. Responsibilities include pre-sale technical consultation, assessment of customer requirements and technical environments, implementation planning, installation and configuration, system integration, upgrades, and troubleshooting.
Job description
Working closely with customer stakeholders in Information Technology (IT), automation engineering, Manufacturing Science and Technology (MSAT), Quality, and other technical functions, the Technical Implementation Specialist translates customer requirements into practical implementation plans and coordinates the activities required for deployment.
Responsibilities
- Owns implementation and technical support of the CGT Technologies portfolio's software application at customer sites.
- Supports pre-sale activities, including technical consultations, assessments of customer requirements and technical environments, product presentations, demonstrations, and responses to requests for information or proposals.
- Defines implementation scope, system prerequisites, responsibilities, dependencies, risks, and completion criteria based on customer requirements and technical environments.
- Develops and manages implementation plans, including installation preparation, configuration, system integration, testing, and upgrades.
- Coordinates implementation activities with customer stakeholders, including Information Technology, automation engineering, Manufacturing Science and Technology, Quality, and other technical functions, to establish expectations and maintain project progress.
- Partners with customers to translate technical requirements into practical solutions related to system configuration, user access, connected devices, external-system interfaces, reporting, and workflows.
- Coordinates with Business Development, the Account Executive role, FAS, Field Service, Technical Support, Engineering, Quality, and other internal stakeholders to align resources, manage project dependencies, and address implementation barriers.
- Provides timely project updates, communicates technical decisions, identifies risks or delays, and coordinates appropriate actions with customer and internal stakeholders.
- Identifies, troubleshoots, and resolves installation, configuration, integration, connectivity, and performance issues, escalating issues to the appropriate internal teams as needed.
- Supports customer testing, validation, change control, and acceptance activities by providing applicable technical information and implementation documentation.
- Participates in customer technical support activities as needed.
- Maintains accurate records of implementation activities, project status, technical decisions, system configurations, risks, and follow-up actions in applicable company systems, including the Customer Relationship Management (CRM) system.
- Gathers and communicates customer feedback to Global Product Management to inform future product development.
- Represents the company at customer meetings and local, regional, and national business events as needed.
- Travels up to 10% to support customer implementations and business objectives.
Requirements
- Bachelor's degree in Computer Science.
- Minimum of 5 years of related experience in software implementation, systems administration, systems integration, technical support, or a related field.
- Demonstrated customer-facing experience implementing, integrating, or supporting software systems in biotechnology, pharmaceutical, medical device, or other regulated manufacturing environments.
- Experience with Microsoft Windows and Windows Server environments, Microsoft SQL Server, databases, web applications, and report generation.
- Working knowledge of networking, Wi-Fi, remote-access technologies, VPNs, firewalls, HTTPS/TLS, and system connectivity troubleshooting.
- Working knowledge of user accounts, role-based permissions, Active Directory, certificates, and web-server administration.
- Experience with web interfaces, APIs, and integration with enterprise or manufacturing systems.
- Experience with computerized system validation, change control, cybersecurity, and 21 CFR Part 11 or EU Annex 11 requirements preferred.
- Strong project-management skills, including the ability to manage multiple customer implementations, priorities, and project dependencies.
- Strong analytical, troubleshooting, and problem-solving skills.
- Excellent written and verbal communication and collaboration skills, with the ability to communicate effectively with technical and nontechnical audiences.
- Proficiency with Microsoft Office applications.
- Ability to travel up to 10% based on business needs.
Requirements
- Bachelor's degree in Computer Science
- Minimum of 5 years of related experience in software implementation, systems administration, systems integration, technical support, or a related field
- Demonstrated customer-facing experience implementing, integrating, or supporting software systems in biotechnology, pharmaceutical, medical device, or other regulated manufacturing environments
- Experience with Microsoft Windows and Windows Server environments, Microsoft SQL Server, databases, web applications, and report generation
- Working knowledge of networking, Wi-Fi, remote-access technologies, VPNs, firewalls, HTTPS/TLS, and system connectivity troubleshooting
- Working knowledge of user accounts, role-based permissions, Active Directory, certificates, and web-server administration
- Experience with web interfaces, APIs, and integration with enterprise or manufacturing systems
- Experience with computerized system validation, change control, cybersecurity, and 21 CFR Part 11 or EU Annex 11 requirements preferred
- Strong project-management skills, including the ability to manage multiple customer implementations, priorities, and project dependencies
- Strong analytical, troubleshooting, and problem-solving skills
- Excellent written and verbal communication and collaboration skills, with the ability to communicate effectively with technical and nontechnical audiences
- Proficiency with Microsoft Office applications
- Ability to travel up to 10% based on business needs
Benefits
- 401(k) Matching
- Paid Vacation
- Holiday & Personal Days
- Employee Assistance Program
- Medical, Dental & Vision
- Life Insurance
- Disability Insurance
- Wellness Program
Company overview
Fresenius Kabi USA is a leading global healthcare company and a subsidiary of Fresenius Kabi AG, specializing in pharmaceutical manufacturing and medical technologies. Headquartered in Lake Zurich, Illinois, the company operates as a comprehensive provider of essential medicines and technologies for critically and chronically ill patients. With over 43,000 employees globally and a presence in more than 100 countries, Fresenius Kabi USA focuses on four complementary business areas: Biopharma (biosimilars for autoimmune diseases and oncology), Pharma (IV drugs and infusion therapy), Medical Nutrition, and MedTech. The company's extensive portfolio includes injectable drugs, delivery systems, advanced transfusion medicine, cell therapy technologies, clinical nutrition products, and infusion devices. Serving hospitals, long-term care facilities, alternate care sites, and clinics, Fresenius Kabi USA is committed to providing high-quality, lifesaving medicines and technologies while driving healthcare transformation through innovation and patient-centric solutions.