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Sr. Application Specialist
Location:
Durham, NC
Description:
Job Description Duties: Develop, create, and modify computer applications software or specialized utility programs by providing technical oversight, developing technical solutions, and delivering high quality requirements for laboratory electronic systems such as LabWare LIMS, Electronic Lab Notebooks, Empower CDS, and potentially other laboratory systems in POT IT Quality and Lab Automation Systems organization. Focus on the software development lifecycle (SDLC) with attention to Data Integrity, FDA & European regulatory requirements, 21 CFR Part 11 and EU Annex 11 guidelines. Understand business function's strategy and effectively translate strategy into opportunities and requirements for technology solutions; prepare detailed specifications from which programs and templates will be written, designed, coded, tested and deployed. Assist with necessary change control and regulatory IT documentation required to demonstrate appropriate compliance, and drive mid to large scale projects, including scope, work breakdown schedules, risks, financials, dependencies, communication and delivery. Lead and own development, technical testing, deployment, and system configuration in Empower CDS, NuGenesis SDMS, and customize LabWare LIMS as needed using LIMS Basic to meet the business requirements. Track and deliver system maintenance tasks and periodic activities such as user reviews, backup and restore testing, incident and change documentation, infrastructure patching and disaster readiness testing as defined in the Biogen quality procedures. Coordinate with internal customers to ensure successful partnerships and effective communication to achieve software development and configuration objectives. Develop relationships with vendors and manage team of internal and external third party technical resources to support the lab systems operations and meet project demands while complying with the Biogen SDLC methodology to ensure the delivery of highly scalable and secure solutions. Identify and realize opportunities to increase the value of the lab systems by extending cost effective use or reducing platform costs through rationalization, consolidation, streamlining, and price negotiation. Interface with regulatory agencies during inspections or audits, as required to support and defend the validated state of lab systems in scope. Provide or arrange for technical support and problem resolution of user inquiries and to resolve production issues; maintain awareness of projects or changes to other corporate wide systems that may affect lab systems and ensure there is no degradation of service. Develop training plans for new or revised systems or applications, leveraging IT, vendors and business resources. Telecommuting permitted up to 100% Qualifications Minimum Requirements : Bachelor's degree or foreign equivalent in computer science, biomedical engineering or related field. Must have five (5) years of related work experience in the job offered or in a Sr. Application Specialist related occupation. Experience must include:5 years of experience with: Computer Systems validation, including experience that leverages application lifecycle management software as part of the solution. Understanding of Good Manufacturing Processes (GMP's), data integrity, change management processes, and relevant industry standards in the pharmaceutical or biotechnology industry. 3 years of experience with each of the following: Assessing laboratory, quality, and manufacturing systems and processes against corporate and regulatory requirements and driving change to ensure compliance in a GxP environment. Working with life sciences systems including LabWare LIMS, LabWare ELN, Empower CDS, Oracle databases, and Crystal Reports. Working on projects in a collaborative team environment utilizing project management skills. Understanding the technology offerings applicable to the business when assisting in the design of technical solutions with consideration of cloud or on premises infrastructure and commercial off the shelf software. 2 years of experience with: Working with Instrument and Equipment software systems that interface with enterprise lab automation systems and/or manufacturing systems. Utilizing software lifecycle methodologies including V Model, and ITIL Framework. Additional Information All your information will be kept confidential according to EEO guidelines. Why Biogen? Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients' lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.PDN-9bbd4f7b-c5f0-4558-bcb6-f4c2e57b1cbf
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More About this Listing: Sr. Application Specialist
Sr. Application Specialist is a Computer & Software Jobs Application Specialist Job at Biogen located in Durham NC. Find other listings like Sr. Application Specialist by searching Oodle for Computer & Software Jobs Application Specialist Jobs.
Sr. Application Specialist is a Computer & Software Jobs Application Specialist Job at Biogen located in Durham NC. Find other listings like Sr. Application Specialist by searching Oodle for Computer & Software Jobs Application Specialist Jobs.