IT Business Systems Integrator - Engineering

This position is an integral part of delivering, maintaining, and supporting products and solutions in a way that drives business value. The technical analyst helps enable business effectiveness by identifying opportunities across business areas for leveraging technology, process, and information. The technical analyst identifies systems requirements and recommends appropriate systems alternatives and/or enhancements to current systems. They serve as thought leader, influences evolution of internal standards, adoption of new technologies, enhancement of existing systems, and process changes.

This role will collaborate with global IT teams to meet goals for both current and anticipated future needs for new and existing technologies, practices and initiatives.

• Create, modify, and enhance applications and systems to satisfy business information demands. Facilitate changes by delivering feedback from customers to application teams and communicate any changes applied ensuring operational procedures stay current and relevant.
• Assure adherence of applicable regulatory (i.e. cGXP, CFR, etc.) practices during execution of all work activities. Participate in audits, inspections, and associated readiness activities.
• Must serve as a technical expert and work with business to identify and capture new opportunities, improve processes, and optimize the value it can provide.
• Ensure that the technology solutions being implemented are compliant with all relevant regulations (i.e. 21 CFR Part 11, Sarbanes Oxley, GxP, privacy data practices, local and corporate policies).
• Provide IT technical and/or validation direction related to computer system Change Management initiatives, as well as the selection, implementation, and upgrade of computerized systems.
• Identify, recommend, and implement automated solutions to address operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. Train and assist business users in proper use of applications and computerized systems.
• Act as lead investigator for issues deemed to have a system root cause, working with Technical SMEs, functional area SMEs and vendors to identify solutions.
• Foster professional and inclusive behavior, invite new ideas and differing perspectives among team members, assuring an on-going positive relationship with the customers and other members of the IT organization. Inspire and recognize teamwork.
• Serve as a technical liaison between local and corporate systems groups, cross-functional or cross-site teams, as requested, interfacing with system owners, IT, QA, Manufacturing, AEG, vendors, and other relevant functional areas. Build enterprise and cross-site connections to ensure integration and results.
• Stay active and current in business technology trends, direction and innovation related to business process and technology areas of focus by participating in external forums, conferences, and other venues as necessary.
• Ensure compliance to corporate and site policies and procedures to be audit ready, mitigate risk, and follow quality management practices. Support and abide by applicable Celltrion policies as indicated in the Code of Conduct and other company policies and procedures. All corporate compliance training requirements must be met as required and defined.

BS/BA in Computer Science or related field required (or equivalent work experience).

• 5+ years IT or equivalent relevant experience.
• Minimum of 2+ years in the Life Sciences industry.
• Must maintain excellent working knowledge of pharmaceutical regulations (e.g. cGMP’s, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.) related to laboratory and/or manufacturing environment and system applications.
• Ability to work on multiple concurrent project initiatives.
• Experience with managing external (vendor, consultant) business partners.
• Basic understanding of databases (Oracle, SQL, etc.) and operating systems (Windows, etc.).

• Previous experience in a regulated environment preferred.
• Effective…