IT Specialist – GMP Systems

Department: Operations The IT Specialist – GMP Systems is responsible for supporting a broad range of needs related to CEL-SCI’s GMP IT infrastructure and the use of electronic devices (i.e., desktop computers, laptop computers, network servers, tablets) that support the manufacturing and testing 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 11.0. The IT Specialist reports to the Operations Department with its primary role to support the validation department during the GMP computer systems validation efforts. Requirements Education & Experience: Bachelor’s degree or equivalent college level training, Computer Science degree preferred5+ years’ experience in a pharmaceutical/biopharmaceutical environmentKnowledge 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 GMPsCapability to suggest and implement working solutions that meet cGMP computer system complianceAbility to administer multiple systems simultaneouslyComfortability to work in a team environment to meet project deadlinesExcellent communication skillsStrong organizational skillsStrong inventory tracking skills Technical Competencies Strong knowledge and abilities in Microsoft Office ApplicationsStrong knowledge of Windows OSStrong Knowledge of Windows Server 2016 and newerWork experience setting up new Windows server from start to finishStrong knowledge of Active Directory, DHCP, DNS, Group PolicyStrong knowledge of router/firewall configuration and maintenanceWork experience with Cisco, Sonic Wall, and/or Ubiquiti router/firewall is a plusStrong knowledge of TCP/IP protocolEntry level knowledge of cloud solutions like Microsoft AzureEntry level knowledge of various computer programming languages Knowledge of SQL Server and SQL programing is a plus Responsibilities Include, But Are Not Limited To 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 guidelinesInitiate, assess, implement, and approve change controls as they relate to IT and GMP computer systemsProvide IT technical review for Standard Operating Procedures (SOPs), Computer Systems Validation (CSV) protocols, equipment specifications, etc., as appropriateImplement system securities and user access management restrictions to ensure data integrityPerform Data Integrity assessments and remediations for GMP computer systems periodicallyDevelop a robust back-up and restoration program for GMP-relevant systems that reside at multiple locationsCollaborate within a team environment to ensure appropriate documentation of IT responsibilities throughout the CSV processAssist 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 activitiesTrain employees on IT procedures applicable to the GMP manufacture and testingSupport the IT consultant in building or repair network hardware and infrastructureRecommend IT purchases as neededProvide help desk services to employeesAdminister GMP computer systems to ensure alignment with GMP policies and proceduresAssist the IT consultant with local workstation permission settings, periodic review and back-upOther duties as assigned Other Ability to stand, walk, and sit for hoursAbility to work in tight environments with little room for maneuveringAbility to lift up to 50 LBS 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.