Computer System Validation Specialist

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 processEngage 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 proceduresFoster 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 fieldProven work experience (3+ years) in IT supporting business operationsExperience in a strongly regulated GxP environment, preferably pharmaceuticalsGood understanding and knowledge of computer systems, mobile devices, networks, and other technology productsAbility to diagnose and troubleshoot basic technical issuesFamiliarity with remote desktop applications and help desk softwareExcellent problem-solving and communication skillsAbility to troubleshoot complex software issues and provide step-by-step technical help, both written and verbalGood time management skills, interpersonal skills, and the ability to think criticallyResilient with the ability to perform in an ambiguous environment and under pressureVersatile with the ability to deliver against strongly regulated requirementsConsistent excellence in both planning and execution

Experience and Education:Master s degree in Computer Science or Information Systems and 8+ years of industry experience ORBachelor s degree in Computer Science or Information Systems and 10+ years of industry experience ORAssociate s degree in Computer Science or Information Systems and 12+ years of industry experience