Information Technology (IT) Specialist 

Posted 4 weeks ago

Position:               Information Technology (IT) Specialist 

Description:

The IT Specialist is responsible for supporting a broad range of needs related to CEL-SCI’s IT infrastructure and the use of electronic devices (i.e., desktop computers, laptop computers, network servers, tablets) that support the manufacturing of our cancer immunotherapy, Multikine, as well as working with the Company’s IT consultant. Digital information assessed by, created by, and stored by CEL-SCI is highly confidential and must be protected from all outside parties. As a biopharmaceutical company making a complex biological drug, the IT Specialist will ensure that CEL-SCI follows Current Good Manufacturing Practices (cGMP) as outlined in the 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 Senior V.P. of Operations.

REQUIREMENTS:

Education & Experience:

  • Bachelor’s degree or equivalent college level training
  • 3+ years’ experience in a pharmaceutical/biopharmaceutical computer network/IT 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 (Computerised Systems)

Skills & Abilities:

  • Strong understanding of regulatory requirements (21 CFR Part 11, Annex 11) as they pertain to computerized systems
  • Strong knowledge and abilities in Microsoft Office Applications
  • Knowledge of Microsoft Server 2013 and newer
  • Strong knowledge and abilities in data base software (Access and others)
  • Strong technical writing and editing skills
  • Strong organizational skills
  • Ability to handle multiple projects simultaneously and meet deadlines
  • Excellent communication skills
  • Working knowledge of electronic document management systems (eDMS)
  • Ability to suggest and implement working solutions that meet cGMP computer system needs cGMP compliance
  • Knowledge of SQL Server and Cisco Routers a plus
  • Knowledge of Mac based systems a plus

Responsibilities include, but are not limited to:

  • Perform Data Integrity assessments and remediations for Laboratory computer systems
  • Developing processes, Standard Operating Procedures (SOPs), and data storage requirements to ensure compliance with regulatory guidelines
  • Initiate, assess, implement, and approve change controls as they relate to IT and computer systems
  • Develop IT policies and procedures that fit within the overall GxP strategy and support quality standards
  • Provide IT technical review for Standard Operating Procedures (SOPs), validation protocols, equipment specifications, etc., as appropriate
  • Implement system securities and user access management restrictions to ensure data integrity
  • Develop a robust back-up and restoration program for GMP-relevant systems that reside at multiple locations
  • Work with the Company’s IT consultants in the documenting and validating of the computer systems utilized in the manufacture and testing of Multikine, as needed
  • Maintain a computer system inventory in accordance with the Computer System Validation Master Plan (VMP)
  • Troubleshoot issues with validated computer systems during GMP manufacturing activities, as needed
  • Train employees on IT procedures applicable to the GMP manufacture and testing
  • Support the IT consultant in building or repairing network hardware and infrastructure
  • Recommend IT purchases as needed
  • Provide help desk services to employees for GMP-relevant systems
  • Administer secure document sharing platform
  • Administer online meeting and screen share platforms (Zoom, Cisco, Microsoft, etc.)
  • Assist the IT consultant review and ensure computer data back-up for all systems
  • Other duties as assigned

Work Hours:

Position is full time. 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.

Location:

Elkridge, MD

We offer competitive salaries, outstanding comprehensive benefits, and Employee Stock Options. 

Please submit cv/resume and cover letter to careers@cel-sci.com.  Reference the job title in the subject line of the email 

DISCLAIMER:

CEL-SCI Corporation is committed to a policy of equal employment opportunity. CEL-SCI will recruit, hire, train, and promote into all job titles the most qualified individuals, without regard to race, color, creed, protected veteran status or disability, gender, religion, marital status, registered domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.

Apply Online