IT Specialist

Position Summary

The IT Specialist is responsible for providing technical support, system administration, and infrastructure maintenance in a GMP-compliant pharmaceutical CDMO environment. This role ensures the secure, reliable, and compliant operation of all IT systems, networks, and applications that support manufacturing, laboratory, and business operations. The IT Specialist will collaborate closely with Quality Assurance, Production, and R&D to ensure all IT solutions meet both operational needs and regulatory requirements.

Key Responsibilities

1. Technical Support & Troubleshooting

• Provide timely end-user support for hardware, software, and network issues.
• Diagnose, troubleshoot, and resolve incidents via phone, email, remote tools, and in person.
• Escalate complex issues to senior IT staff or vendors as necessary.

2. System Administration

• Install, configure, and maintain workstations, servers, printers, and mobile devices.
• Administer Active Directory, email systems, user accounts, and permissions.
• Manage and maintain data backup, disaster recovery, and storage solutions.

3. GMP & Regulatory Compliance

• Ensure all IT systems and processes comply with GMP, FDA, and other applicable regulatory guidelines.
• Support Computer System Validation (CSV) activities, including documentation, change control, and periodic reviews.
• Maintain detailed records of system configurations, updates, and incidents in compliance with audit requirements.

4. Network & Security

• Monitor and maintain LAN/WAN, wireless networks, and internet connectivity.
• Apply security updates, patches, and antivirus protection.
• Assist in implementing cybersecurity best practices and incident response procedures.

5. Collaboration & Projects

• Partner with cross-functional teams to support IT requirements for manufacturing, laboratory, and administrative operations.
• Assist in planning and executing IT infrastructure upgrades, migrations, and implementations.
• Provide technical input during audits, inspections, and customer visits as needed.

Qualifications

Education & Experience:

• Associate’s or Bachelor’s degree in Information Technology, Computer Science, or related field preferred.
• 2 years of experience in IT support or system administration, preferably in a pharmaceutical, biotech, or GMP-regulated environment.

Skills & Competencies:

• Significant GMP experience
• Strong knowledge of Windows operating systems, Microsoft 365, and networking fundamentals.
• Experience with Active Directory, file permissions, and group policies.
• Familiarity with ERP, LIMS, MES, or other laboratory/manufacturing systems (preferred).
• Understanding of GMP, 21 CFR Part 11, and data integrity requirements (preferred).
• Excellent troubleshooting, communication, and customer service skills.
• Ability to handle multiple priorities in a fast-paced, regulated environment.

Preferred Certifications:

• CompTIA A (IT support fundamentals)
• CompTIA Network (networking basics)
• HDI Support Center Analyst (HDI-SCA) or HDI Desktop Support Technician (HDI-DST)
• Microsoft Certified: Modern Desktop Administrator Associate
• ITIL® Foundation (IT service management best practices)

Physical Requirements

• Ability to lift up to 25 lbs. for equipment installation.
• Ability to sit or stand for extended periods.
• Occasional after-hours or weekend work to support system maintenance or project deadlines.

Work Environment

• Office and manufacturing/laboratory settings with exposure to cleanroom environments.
• Strict adherence to company safety, security, and GMP policies is required.