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Job Description: Validation and IT Systems Specialist

Location: Cranbury, NJ (Hybrid: 3 days in office)
Duration: 12 months
Experience: 8+ years-10 yrs

Skills Experience as per JD

No of years’ experience

Beginner / Intermediate / Advanced

Experience in validation and/or IT systems support, preferably in FDA-regulated environments.

 

 

Experience and understanding of FDA regulatory requirements and 21 CFR compliance

 

 

Experience on Computer system validation (CSV) and GMP compliance.

 

 

Familiarity with IT infrastructure, including networking and application configuration.

 

 

 

 

 

We are seeking a 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.

 

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.
 

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.
 

 

Make sure the resource has an idea of the below

 

Hardware Qualification
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 (e.g., Oracle, SQL Server) hosting regulated data.
Backup and recovery processes.
Virtualization Platforms
Virtual machines and hypervisors (e.g., VMware, Hyper-V).
Ensure proper allocation of resources and isolation of environments.
Security and Access Control
User authentication (e.g., 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 (e.g., access control, fire suppression).
Environmental conditions (e.g., 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.