Job Description
Summary: Our client, a biopharmaceutical company located in Waterford, is seeking a QC IT Systems Engineer. The ideal candidate will focus on managing and optimizing the IT infrastructure and digital systems that underpin Quality Control (QC) operations. This involves ensuring that QC systems, applications, and hardware operate efficiently and securely, and integrating these systems with both enterprise and local automation systems, including IoT devices, to facilitate seamless data availability for analysis and decision-making. The successful candidate will also be providing technical expertise for the implementation and maintenance of digital products and IT solutions, thereby improving QC processes. Additionally, the incumbent is responsible for enhancing business operations through analytics and IT tools to gain insights and commercial advantages, all while ensuring cybersecurity and regulatory compliance and maintaining overall system performance and data integrity. Responsibilities: Manage and implement key IT operations, including operating systems, security tools, software applications, servers, laptops, desktops, thin clients, printers, hardware, and software solutions. Lead and own specific projects and solutions as part of broader business initiatives, ensuring successful execution and delivery. Oversee and support critical IT and digital systems that drive commercial advantages in a global market. Enhance business processes through the implementation of analytics for faster and smarter decision-making. Collaborate with internal teams, external partners, and vendors to provide updates on project status, activities, and accomplishments. Provide both application and technical expertise throughout project execution phases. Support the integration of quality and digital systems with enterprise and local automation systems, including IoT devices, ensuring data availability through Plant Connectivity while adhering to cybersecurity standards. Ensure compliance to cGMP (current good manufacturing practice) at all times and SOX Compliance. Compliance with all quality documents, site & global, audit support & CAPA / deviation management. Qualifications & Experience: A third-level degree in computer science, information technology or engineering (e.g., software engineering, systems engineering). A minimum of 3 years' experience in a similar role, preferably in a GxP environment, is required. Documentation skills, ability to create detailed technical specifications and documentation. PC Hardware/operating systems, proficient in both modern and legacy PC hardware and operating systems. Lab instrumentation knowledge, experience with laboratory instruments such as balances, pH meters, HPLCs, etc., with a focus on network connectivity for these devices. Networking fundamentals, strong understanding of networking concepts including TCP/IP, VLAN, firewall configurations, remote administration, and active directory management. Previous experience working in or supporting a pharmaceutical lab environment is a plus. Familiarity with good manufacturing practices (GMP), GAMP5, and CFR21 Part 11 compliance is advantageous. Skills: Quality Control CAPA IoT