Validation and IT Systems Specialist | Sesheng LLC

West Windsor, NJ (Hybrid: 3 days in office)

We are seeking a highly motivated and experienced Validation and IT Systems Specialist to join our dynamic team. This role combines expertise in validation and computer system validation (CSV) with IT administrative support for regulated systems and applications. You will play a critical role in ensuring the compliance of our IT systems with 21 CFR requirements and supporting the smooth operation of our regulated business processes.

Key Responsibilities:

Validation Expertise

• Ensure compliance with 21 CFR requirements for FDA-regulated systems.
• Conduct and manage GMP assessments for instruments and categorize them appropriately.
• Develop and execute validation strategies, protocols, and reports to meet regulatory and business requirements.
• Collaborate with cross-functional teams to manage the validation lifecycle for new and existing systems.

IT Administrative Support

• Provide administrative support for IT systems and applications, ensuring smooth operations in a regulated environment.
• Manage system configurations, troubleshooting, and maintenance in collaboration with IT teams.
• Support the software development lifecycle, ensuring alignment with validation and compliance standards.

Technical Understanding

• Maintain a foundational understanding of IT infrastructure, including networking, connectivity, and application configurations.
• Work effectively with technical teams to support system implementation, upgrades, and issue resolution.

Adaptability and Problem Solving

• Proactively address challenges in a fast-paced, deadline-driven environment.
• Prioritize tasks effectively and ensure timely completion of projects.
• Demonstrate sound judgment and common sense in navigating complex scenarios.

Hardware Qualifications

• Servers: Physical and virtual servers hosting regulated applications.
• Storage Systems: Network-attached storage (NAS) or storage area networks (SAN).
• Workstations: User endpoints interacting with validated systems.
• Peripherals: Printers, scanners, and other auxiliary devices used in regulated processes.

Networking

• Switches and Routers: Ensure proper installation and configuration of network devices.
• Firewalls: Validate security configurations and data flow integrity.
• Connectivity: Test and document network performance, including latency and bandwidth.

Operating Systems (OS)

• Installation and configuration of operating systems supporting validated applications.
• Patch management and periodic updates to ensure compliance and security.

Database Systems

• Qualification of database servers and configurations ( Oracle, SQL Server) hosting regulated data.
• Backup and recovery processes.

Virtualization Platforms

• Virtual machines and hypervisors (VMware, Hyper-V).
• Ensure proper allocation of resources and isolation of environments.

Security and Access Control

• User authentication (Active Directory, LDAP).
• Role-based access controls (RBAC) and segregation of duties.

Disaster Recovery and Backup

• Backup systems, procedures, and recovery testing.
• Validation of data integrity during recovery processes.

Environmental Controls

• Physical security of data centers (access control, fire suppression).
• Environmental conditions (temperature and humidity monitoring).

IT Infrastructure Qualification Process

• System Risk Assessment: Evaluate the impact of the infrastructure on regulated systems. Categorize components based on risk and regulatory significance.
• Documentation:
• IQ Protocol: Define the installation and configuration steps.
• Test Scripts: Include checks for hardware, network, OS, and database configurations.
• Validation Summary Report: Summarize testing results and confirm compliance.
• Installation Qualification (IQ): Verify hardware and software components are installed per manufacturer specifications.
• Operational Qualification (OQ): Test the functionality of infrastructure components under normal and stress conditions.
• Performance Qualification (PQ): Validate the infrastructure’s ability to support operational requirements over time.
• Change Control: Implement and document processes for infrastructure updates, patches, and changes.

Qualifications

• Education: Bachelor’s degree in a relevant field such as Computer Science, Life Sciences, or Engineering.
• Experience: Minimum 8 years of experience in validation and/or IT systems support, preferably in FDA-regulated environments. Proven expertise in computer system validation (CSV) and GMP compliance. Familiarity with IT infrastructure, including networking and application configuration.
• Skills: Strong understanding of FDA regulatory requirements and 21 CFR compliance. Excellent problem-solving and prioritization abilities. Strong interpersonal and communication skills for cross-functional collaboration.

We are an Equal Opportunity Employer and value diversity in our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to building a diverse and inclusive workforce where everyone feels valued, respected, and empowered to succeed.