| INFRASTRUCTURE SPECIALIZING CSV. & Senior MongoDB Engineer with DevOps Baltimore, MD local only at Baltimore, Ohio, USA |
| Email: [email protected] |
| Hello, Hope you are doing well! Suryaprakash [email protected] Greetings from Sapphire Software Solutions Inc., As a global staff augmentation company, Sapphire Software Solutions offers comprehensive workforce solutions and a large pool of personnel available on demand. If you have someone available for the following role, do let me know: INFRASTRUCTURE SPECIALIZING CSV. Must have hands on network exp! They are doing an office MOVE! If you have candidates please provide details on their infra background and MOVE exp. 100% remote USC/GC PAY- 55/hr C2C Our client is looking for a Senior Computer Systems Validation (CSV) Infrastructure Specialist to support GxP relevant applications meets or exceeds regulatory expectations for compliant infrastructure platforms, both traditional and cloud based. This includes the qualification and control of IT Infrastructure that is impacted by GxP regulations set forth by the FDA, EU, and other regulatory bodies. Under the direction of the CSV Lead, the Sr CSV Infrastructure Specialist will lead the overall development and maintenance of risk-based IT Infrastructure lifecycle documentation as specified in the Quality Management System that will provide documented evidence that the GxP IT Infrastructure is compliant and fit for its intended purpose. Requirements: Develop and manage GxP Infrastructure Qualification lifecycle documentation, including Validation Plans, Specifications, Testing Protocols (IQ), Traceability Matrix, SOPs, Change Control, Risk Assessments, and Validation Reports. Conduct Infrastructure Qualification compliance risk assessments in accordance with standard operating procedure. Support Infrastructure Qualification efforts and act as the primary user/sponsor contact for coordinating work, reporting status, resolving issues, and addressing change control requests as they apply Support complex technical quality requirements in specific IT Infrastructure and CSV situations, such as validation of new systems, upgrades, changes, or remediation, etc. Provide guidance, interpretation, and ensure compliance with CSV and IT related regulations, quality manuals, company policies, and procedures. Provide technical input to address validation deviations: providing technical assessments for change requests; identifying qualification/validation requirements to ensure GxP compliance; and performing technical reviews of validation deliverables. Interface with internal stakeholders to analyze data and situations leading to sound decision making. Skill/Experience/Education Bachelors degree in computer science or engineering discipline or relevant working experience, 10+ years of experience in the field of Computer System Validation and IT Infrastructure Qualification in the Pharmaceuticals, Life Sciences, and Healthcare industries. 10+ years experience in Good Manufacturing Practice (GMP) / QA within Food and Drug Administration (FDA) regulated environments. Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (e.g., FDA, EMEA, GCP, GLP, GMP, QSR, etc.) and internal requirements employing regulatory guidance and industry standards. Working knowledge and the practical application of the following: GAMP 5 risk-based approach to compliant computerized systems. GAMP Good Practice Guide for IT Infrastructure Control and Compliance Experience with FDA 21 CFR Part 11 compliance. Experience with Eudralex, Volume 4 - Annex 11 compliance Ability to communicate verbally and especially in writing at a professional level and to distill complex technical terms to a layperson's understanding with conciseness, clarity, and accuracy. Excellent writing skills (functional/technical specifications) are required. Strong relationship building skills and ability to work well in a multi-cultural environment. Demonstrates attention to detail and possess strong analytical skills. Possess the ability to multitask and work independently or in a team environment with minimal supervision Possess good interpersonal and strong written/verbal communication skills Well developed skills in prioritizing, organization, and time management Highly motivated and detail oriented with good organizational skills Ability to work in a dynamic, fast paced environment with shifting priorities Works on complex problems where analysis of situations or data requires evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Builds productive relationships internally and externally. Frequent contacts with peers and vendors concerning projects, operational decisions, scheduling requirements, or contractual clarifications. Senior MongoDB Engineer with DevOps Baltimore, MD local only Key required skills: Strong knowledge of Mongo Community Edition on Linux, MongoDB architecture and experience with scripting automation Position description: Automate and maintain MongoDB databases and infrastructure using Community Edition on Linux. Attend all customer technical discussions/design/development meetings and provide technical inputs to further enhance the code quality/process. Provide guidance/support to other junior/mid-level developers. Impact functional strategy by developing new solutions, processes, standards, or operational plans that position Leidos competitively in the marketplace. All other duties as assigned or directed. Minimum qualifications: Bachelor's Degree in Computer Science, Mathematics, Engineering, or a related field 7+ years of overall experience - Master's or Doctorate degree may substitute for required experience 5+ years of experience with MongoDB Community Edition on Linux. 3+ years of hands-on experience in DevOps Excellent communication skills. Required skills: Excellent communication and written skills. Previous work in DevOps Environments. Hands-on experience with Mongo Community edition. Familiar with Mongo internals and how Mongo works outside of a GUI environment. Designing, building, and automating the Infrastructure for MongoDB Community Edition. Experience in using Python, Ansible, or similar methods to automate infrastructure tasks. Experience with Shell Scripting. Knowledge of MongoDB architecture. Strong debugging and troubleshooting skills. Standout skills: Experience with modern development software, tools, and methodologies. Experience working on Agile projects and understanding Agile terminology. Ansible Automation experience. Git/Bitbucket, Confluence, JIRA experience Experience on automating AWS ElastiCache provisioning, administration, and maintenance. Experience working with AWS database services including RDS, EC2, S3 Candidate should be able to work independently as well as in a team. Title: Java Application Developer Client: Commonwealth of MA EOHHS Location: Boston Hybrid Onsite Interview: Final Round Onsite in Boston Duration: 12+ months Details: Developer and troubleshoot midrange Java applications including XML. Expert in Object Oriented Analysis and Design using Java and UML Extensive use of Eclipse (commonly used plug-ins and debug techniques) Expert is SOAP, REST services specifically Apache CXF. Experience in using Java frameworks Spring or similar frameworks, and JQuery. Extensive technical experience and development expertise in Core Java, J2EE, JSP, Servlets, Struts, Web services, Spring, Hibernate, Java Script, and AJAX. Please DO NOT copy/paste this content to any job boards Do NOT reference Beacon Hill Staffing Group or End Client Name in any job posting or job boards -You are not authorized to reference BHSG or the end client name in any advertisement. REMINDER ALL SUBMITTALS MUST BE ABLE TO PROVIDE at the point of an offer: All years of US based work experience W2s and pay stubs Education verification documents A valid copy of their work authorization This email is generated using CONREP software. A10980 Keywords: quality analyst sthree information technology green card wtwo Maryland Massachusetts |
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| Thu Feb 15 09:28:00 UTC 2024 |