Lab Systems Lead

at  SimoTech

ABOUT SIMOTECH

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.

QUALIFICATIONS

• 10+ years’ experience in a Lab IT systems management environment.
• Minimum of 3 days per week required on site.
• Experience with LIMS, lab automation systems, and other laboratory software.
• Proven track record of managing IT projects in regulated environments, including GMP or GLP labs.
• Strong understanding of industry regulations and standards including FDA 21 CFR Part 210 and 211, Eudralex Annex 11 and GAMP5.
• Experience implementing data integrity ALCOA+ principles.
• Be knowledgeable on compliance systems including Veeva Vault, Trackwise, Compliance Wire, and Kneat.
• Have a working knowledge of risk assessments.
• Excellent verbal and written communication skills.
• Strong analytical and problem-solving skills.
• Excellent attention to detail.
• Comfortable working in a dynamic environment, with the ability to manage multiple projects and adapt to changing lab requirements.

• Manage the installation, configuration, qualification, and ongoing support of laboratory instruments, including HPLCs, LCs systems, UV detectors, FTIR, and pH/conductivity from vendors.
• Work closely with scientists, researchers, and lab technicians to understand their IT needs, ensuring that systems meet operational requirements and support research or production activities.
• Ensure data integrity, accuracy, and security across all laboratory systems, adhering to regulatory requirements such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and 21 CFR Part 11.
• Lead and manage IT projects in the lab environment, including system upgrades, installations, migrations, and the integration of new technologies.
• Ensure that lab IT projects are completed on time and within budget.
• Manage relationships with external vendors, ensuring they deliver necessary support and services for lab IT systems, including software updates, hardware maintenance, and troubleshooting.
• Ensure all laboratory IT systems are validated (IQ, OQ, PQ), documented, and compliant with regulatory standards, in conjunction with Quality and Compliance teams.
• Proactively identify opportunities to improve lab IT systems and processes, including automating routine tasks, enhancing data analytics capabilities, and optimising system performance.
• Act as the primary point of contact for troubleshooting and resolving IT related issues within the lab environment, ensuring minimal disruption to laboratory operations.
• Provide training to laboratory personnel on the use of IT systems and tools, ensuring users are proficient and compliant with organisational IT policies.
• Lead digital initiatives within the lab to modernise systems and processes, including the adoption of IoT, and data driven technologies that support smart labs.