GxP Lab Computing Engineer

GxP Lab Computing Engineer The GxP Lab Computing Engineer plays a key role in supporting laboratory technology environments by delivering consulting, analytical, and hands-on technical services. This includes supporting multi-vendor scientific instruments, managing IT infrastructure within lab spaces, and ensuring compliance and validation activities align with regulatory standards. The role requires both technical expertise and strong communication skills to bridge scientific, IT, and compliance teams. Key Responsibilities Consulting and Technical Support • Partner with research and quality teams to assess current lab systems and identify opportunities for improvement. • Deliver in-lab support for instrumentation and connected computer systems, including troubleshooting software, hardware, and network issues. • Collaborate with vendors and internal IT to ensure proper system configuration, security, and performance. • Provide technical oversight for system upgrades, validations, and integrations with enterprise platforms. Compliance and Validation • Support or lead validation efforts for GxP and regulated environments, including authoring or executing IQ/OQ/PQ documentation. • Ensure systems comply with company policies and industry standards (e.g., GLP, GMP, 21 CFR Part 11). • Maintain appropriate documentation, audit trails, and validation artifacts for all laboratory computing systems. Customer and Stakeholder Engagement • Serve as the main point of contact between lab users, IT teams, and external service providers. • Coordinate system maintenance, vendor visits, and equipment downtime schedules. • Develop reports, system metrics, and operational reviews for laboratory leadership teams. • Provide end-user training and ensure adherence to lab safety and IT security procedures. Project and Requirements Management • Gather and document user requirements for lab system implementations or enhancements. • Define project scope, success criteria, and timelines in collaboration with stakeholders. • Analyze workflows and propose process improvements aligned with best practices in laboratory informatics. • Contribute to proof-of-concept evaluations for new lab technologies. Qualifications • Bachelor’s or Master’s degree in Biotechnology, Biomedical Engineering, Chemistry, Computer Science, or a related discipline. • Minimum 5 years of experience supporting laboratory systems or IT in a regulated environment. • Hands-on experience with system validation, requirements gathering, and software testing. • Strong analytical, problem-solving, and organizational skills with the ability to manage multiple concurrent initiatives. • Excellent communication and interpersonal skills to collaborate across scientific and IT teams. • Familiarity with lab workflows such as sample management, materials tracking, or robotics integration. • Understanding of GxP, GLP/GMP, and FDA compliance requirements preferred. Technical Expertise • Proficiency with operating systems such as Windows and/or Linux. • Working knowledge of system lifecycle methodologies (Waterfall or Agile). • Experience with change management, documentation control, and risk assessment. • Competence in Microsoft Office applications (Word, Excel, PowerPoint) and productivity tools such as Visio, MS Project, or SharePoint.