Website LanceSoft Inc
LanceSoft Inc
Company : LanceSoft Inc
IT Engineering Specialist
Responsibilities of the IT Engineering Specialist include, but are not limited to:
" Responsible for the delivery of global, site-specific, and compliant IT solutions within the TechOps IT portfolio and provide operational support.
" Ensure delivery of IT solutions to QC labs, R&D labs, and manufacturing.
" Perform installation, configuration, support, and administration of computer systems and lab instruments in a regulated GMP environment.
" Provide maintenance and support requests to address IT operational issues on assigned technologies, following established processes and procedures.
" Collaborate with business groups, vendors, and cross-functional teams to deliver innovative, scalable, and compliant IT solutions.
" Document user and functional requirements.
" Support IT architecture by working closely with enterprise architects and following established guidelines. Present solutions architecture the architecture review board.
" Design and implement site specific, regional, global, enterprise, and other IT solutions. Author detailed design specifications, architecture and data flow diagrams.
" Author and execute test scripts. Work with vendors and quality teams on authoring and execution of IQ/OQ/PQ to qualify IT solutions.
" Follow SDLC, PMM, Agile and other methodologies for projects and systems delivery.
" Work closely with project managers and the PMO on scheduling and monitoring progress of initiatives. Provide project tasks estimates Contribute to the discussions about resource allocation and capacity planning.
" Address project constraints, including risks and issues. Follow project change control for managing scope and schedule.
" Collaborate with internal & external stakeholders to diagnose and resolve IT issues.
" Ensure the availability and functionality of both hardware and software systems for daily operations, providing technical support on-site or remotely when necessary.
" Manage changes in accordance with GxP and IT change control processes, ensuring SLAs and KPIs are consistently met.
" Stay aligned with domain architecture teams to ensure global consistency, influencing changes to standards when needed.
" Document process steps and systems enhancements required to support process
" Engage with internal clients and stakeholders to address issues with quality and manufacturing systems.
" Analyze security protection technologies, adhering to Corporate IT security policies and guidelines.
" Develop a deep understanding of the business processes and all applicable procedures
" Foster strong relationships with clients and stakeholders.
" Ensure alignment between manufacturing sites and corporate IT for global consistency.
Qualifications:
" Experience with quality labs and manufacturing instruments, IT solutions, operating systems, security concepts, infrastructure, and systems configurations and customization.
" Previous experience working in a GxP environment supporting biotech/pharma technology solutions.
" Strong knowledge of commissioning, qualification, and validation processes.
" Experience with system integration and the ability to engage with stakeholders at all levels in an international environment.
" Demonstrated ability to work under indirect supervision and managing multiple competing priorities concurrently.
" Strong planning and execution skills, with a systematic approach to problem solving.
" 5-7 years of experience related to IT systems management, IT operational support or other information technology solutions roles, ideally in an international setting.
" Excellent oral and written communication skills.
" Strong analytical and problem-solving skills.
" High attention to detail in both technical and administrative tasks.
" Broad knowledge of IT topics, with proficiency in working in a secure network environment.
" Resilience and adaptability to perform effectively in an ambiguous and high-pressure environment.
" Honest and credible, and effective in communication.
Preferred Qualifications:
" BS degree in Information Technology, Computer Science, or relevant field
" Proven work experience (3+ years) in IT supporting business operations
" Experience in a strongly regulated GxP environment, preferably pharmaceuticals
" Good understanding and knowledge of computer systems, mobile devices, networks, and other technology products
" Ability to diagnose and troubleshoot basic technical issues
" Familiarity with remote desktop applications and help desk software
" Excellent problem-solving and communication skills
" Ability to troubleshoot complex software issues and provide step-by-step technical help, both written and verbal
" Good time management skills, interpersonal skills, and the ability to think critically
" Resilient with the ability to perform in an ambiguous environment and under pressure
" Versatile with the ability to deliver against strongly regulated requirements
" Consistent excellence in both planning and execution
Experience and Education:
" Master s degree in Computer Science or Information Systems and 8+ years of industry experience OR
" Bachelor s degree in Computer Science or Information Systems and 10+ years of industry experience OR
" Associate s degree in Computer Science or Information Systems and 12+ years of industry experience