Job Description

Lab Systems Lead: Critical Role in Laboratory Automation

A high-level position responsible for overseeing the administration, integration, and management of IT systems within the laboratory environment.

About Simo Tech

Simo Tech provides manufacturing automation and IT systems engineering, project management, and validation services.

Partnering with life sciences companies, we design, build, operate, and optimize critical process automation systems that deliver fast project delivery, operational efficiency, and manufacturing agility while achieving regulatory compliance.

Why This Role?

This is a unique opportunity to work in a collaborative, fast-paced environment where you will play a critical partnering role in delivering life-changing products to patients.

In return, you will have the opportunity to develop new skills, enhance your technical ability, and work with innovative technologies in a multi-disciplined environment.

Key Responsibilities

• 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 optimizing 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 organizational IT policies.
• Lead digital initiatives within the lab to modernize systems and processes, including the adoption of IoT and data-driven technologies that support smart labs.

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.
• Knowledge of compliance systems, including Veeva Vault, Trackwise, Compliance Wire, and Kneat.
• 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.