Information Systems Engineer III

Employer
Novavax
Location
Gaithersburg, MD
Posted
Jul 01, 2022
Closes
Jul 08, 2022
Ref
584683114
Hours
Full Time
Novavax, Inc. seeks an Information Systems Engineer III in Gaithersburg, MD. Duties: Implementing, supporting and maintaining Quality information systems (Document management, Quality Change control, Deviation/CAPA, LMS etc.) and other Information Systems. Developing and implementing processes to ensure high availability of all systems and taking immediate control of production problems and driving them to resolution. Retrieving, updating and closing out the IS Help Desk tickets with clearly documented resolutions with proper instructions if needed. Documenting Systems support, processes and procedures including backup and recovery. Following change control process throughout system life cycle. Interact with client on a regular basis to understand and fulfill their needs and provide end user training on technical solutions. Coordinating, documenting and participating in key process improvements and provide and implement solutions by coordinating with IT, business and other impacted groups. Troubleshooting system/technology problems, taking appropriate corrective action and/or interacting with IT staff or vendors in performing testing, support, and troubleshooting functions. Telecommuting is permitted 2-3 days a week. Up to 10% domestic and international travel required. Requires a Bachelor's degree in Biotechnology or related field, plus 8 years of experience in related roles. Additional requirements: 8 years of experience working with quality information systems; 8 years of experience with practical knowledge and application of cGMPs (industry experience and awareness) especially relating to quality assurance processes and procedures; 8 years of experience with working knowledge of system application life cycle (SDLC) or Application development life cycle (ADLC); 3 years of experience working with Laboratory systems (eg LabVantage LIMS, Agilent OpenLab, Hamilton MicroLab, or Cytiva A$ -A cents € zKTA, Biacore, and Unicorn); 2 years of experience with Computer System Validation (CSV) and GAMP5; 2 years of experience with ITIL, COBIT, or other IT good practices. As an alternative, employer will accept a Master's degree in Biotechnology or related field, plus 6 years of experience in related roles. Additional requirements: 6 years of experience working with quality information systems; 6 years of experience with practical knowledge and application of cGMPs (industry experience and awareness) especially relating to quality assurance processes and procedures; 6 years of experience with working knowledge of system application life cycle (SDLC) or Application development life cycle (ADLC); 3 years of experience working with Laboratory systems (eg LabVantage LIMS, Agilent OpenLab, Hamilton MicroLab, or Cytiva A$ -A cents € zKTA, Biacore, and Unicorn); 2 years of experience with Computer System Validation (CSV) and GAMP5; 2 years of experience with ITIL, COBIT, or other IT good practices. Employer will accept any suitable combination of education, training, and/or experience. 40 hours/week. Must also have authority to work permanently in the US Applicants who are interested in this position may apply to Ref #19659. Novavax, Inc. will accept applications for this position based on referrals from Novavax, Inc. employees for purposes of their employee referral program. #LI-RB Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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