Technical Implementation Specialist

Job 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.

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.

The role partners with Business Development, the Account Executive role, FAS, Field Service, Technical Support, Engineering, Quality, and other internal stakeholders to manage project dependencies, address implementation barriers, and provide clear communication throughout the project.

The Technical Implementation Specialist also gathers and communicates customer feedback to Global Product Management to inform future product development.

Salary Range: $100,000-$110,000 based on experience * Position is eligible to participate in a bonus plan with a target of 10% of the base salary (include only if applicable to the grade level) * Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. * Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most.

Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

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.
• Participates in any and all reasonable work activities as assigned by management.

Ensures compliance with company documents, programs, and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, consistent with the role's responsibilities.

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.
• The Company's primary business language is English.

The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program. Please note that joining our team does not create a guaranteed or permanent employment arrangement.

All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.