IT Business Systems Integrator – Quality, Health & Safety

Overview

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.

• Must have a combination of technical and soft skills to effectively collaborate with cross-functional teams and drive continuous improvement by engaging with QA and HSE business partners and/or sites to proactively seek opportunities to deliver business value.
• Must utilize your technical expertise to design, develop, implement, improve, and maintain IT tools employed by QA and HSE teams. This includes configuring tools and managing their interaction to support business processes.
• 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 IDS organization. Inspire and recognize teamwork.
• Serve as a 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.
• Ensures that incident, problem, configuration, and change/release management are all done with alignment and understanding of business need and activities to meet quality and compliance standards.

• 5+ years IT or equivalent relevant experience.
• BS/BA in Computer Science or related field required (or equivalent work 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.)…