IT Specialist – GMP Systems

Department: Operations

About the role

The IT Specialist – GMP Systems supports CEL-SCI’s GMP IT infrastructure and electronic devices (desktop computers, laptop computers, network servers, tablets) used in the manufacturing and testing of the cancer immunotherapy Multikine. This role ensures the protection of highly confidential digital information and compliance with Current Good Manufacturing Practices (cGMP) as outlined in US Code of Federal Regulations (CFR) Title 21 Parts 210 and 211, Part 11, and European Union (EU) Annex 11. The IT Specialist reports to the Operations Department and primarily supports the validation department during GMP computer systems validation efforts.

Requirements

• Bachelor’s degree or equivalent college-level training; Computer Science degree preferred
• 5+ years’ experience in a pharmaceutical/biopharmaceutical environment
• Knowledge of FDA Title 21, Parts 210 and 211 cGMP (Current Good Manufacturing Practices), Part 11 (Electronic Records/Electronic Signatures), and EU Annex 11 (Computerized Systems)

Skills & Abilities

• Strong understanding of Computer System GMP regulatory requirements (21 CFR Part 11, Annex 11)
• Strong technical writing and editing skills to draft IT Program Documents that support GMPs
• Capability to suggest and implement working solutions that meet cGMP computer system compliance
• Ability to administer multiple systems simultaneously
• Comfortability to work in a team environment to meet project deadlines
• Excellent communication skills
• Strong organizational skills
• Strong inventory tracking skills
• Strong knowledge and abilities in Microsoft Office Applications
• Strong knowledge of Windows OS
• Strong knowledge of Windows Server 2016 and newer
• Work experience setting up new Windows servers from start to finish
• Strong knowledge of Active Directory, DHCP, DNS, Group Policy
• Strong knowledge of router/firewall configuration and maintenance
• Work experience with Cisco, Sonic Wall, and/or Ubiquiti router/firewall is a plus
• Strong knowledge of TCP/IP protocol
• Entry-level knowledge of cloud solutions like Microsoft Azure
• Entry-level knowledge of various computer programming languages
• Knowledge of SQL Server and SQL programming is a plus
• Ability to stand, walk, and sit for hours
• Ability to work in tight environments with little room for maneuvering
• Ability to lift up to 50 lbs

Responsibilities

• Develop IT policies, Standard Operating Procedures (SOPs), and data storage requirements that fit within the overall GxP strategy and support quality standards to ensure compliance with regulatory guidelines
• Initiate, assess, implement, and approve change controls as they relate to IT and GMP computer systems
• Provide IT technical review for Standard Operating Procedures (SOPs), Computer Systems Validation (CSV) protocols, equipment specifications, etc., as appropriate
• Implement system securities and user access management restrictions to ensure data integrity
• Perform Data Integrity assessments and remediations for GMP computer systems periodically
• Develop a robust back-up and restoration program for GMP-relevant systems that reside at multiple locations
• Collaborate within a team environment to ensure appropriate documentation of IT responsibilities throughout the CSV process
• Assist in the maintenance of a computer system inventory in accordance with the Computer System Validation Master Plan (VMP)
• Troubleshoot issues with computer systems during GMP manufacturing activities
• Train employees on IT procedures applicable to the GMP manufacture and testing
• Support the IT consultant in building or repair network hardware and infrastructure
• Recommend IT purchases as needed
• Provide help desk services to employees
• Administer GMP computer systems to ensure alignment with GMP policies and procedures
• Assist the IT consultant with local workstation permission settings, periodic review, and back-up
• Other duties as assigned

Schedule

• Full-time position, Monday through Friday
• Occasional evening and weekend work may be required
• Travel to the R&D laboratory facility in Baltimore, MD (20 minutes north) will be required
• Must be able to work non-standard hours (weekends, evenings, nights) as needed

Benefits

• Competitive salaries
• Outstanding comprehensive benefits
• Employee Stock Options

Location

Elkridge, MD