Systems Administrator

Pay

65-75 per hour, depending on experience.

The Principal System Administrator will define requirements for implementation of software systems and manage ongoing operations as the primary interface between Operations and IT. Primary platforms will be LIMS and E  applications. The role supports data integrity efforts to ensure compliance to 21

CFR Part 11 for manufacturing and lab equipment.

• Develop and maintain system configuration documentation and plans for new product, equipment, and workflows. Provide first line of troubleshooting for users.
• Manage the operations of systems in a validated environment and develop policies and procedures related to compliance requirements; work with end users to develop user requirements and configuration documents and manage vendor IQ/OQ of equipment.
• Develop, revise, and review SOPs, protocols and reports and other documents to support equipment, platforms, and other computerized systems.
• Develop and provide computerized system training to new users, grant system access, and ensure lab compliance with applicable cGMP regulations and SOPs, and support internal and external audits; collect and report metrics.
• Manage system updates, change controls and maintenance activities as relating to systems.
• Troubleshoot issues, solve problems, and assist with investigations and deviations related to software systems.
• Create/manage master data to support existing/new system functionalities.
• Ensure integrity and accuracy of all documents and assess overall compliance with protocols, SOPs, company policies and applicable regulations.

• B.S. in biological sciences, cell biology, chemistry, or related field with 7+ years of experience, or M.S. with 5+ years of relevant experience working with analytical computerized systems.
• Prior laboratory hands‑on experience with analytical computerized systems.
• Expertise in regulations governing data integrity and computerized systems.
• Experience in qualification of analytical equipment, including those with computerized systems.
• Experience with electronic document management systems.
• Strong interpersonal skills, highly collaborative within a multi‑discipline team and contributes to a supportive and positive work environment.
• Strong knowledge of GMP, SOPs and quality control processes.
• Strong knowledge of quality systems and regulatory requirements.
• Experience and knowledge in implementation and management of LIMS.
• Experience in translating laboratory user requirements to IT implementations.
• Experience with Windows OS, domains, networks and basic computing infrastructure in lab/production environment.
• Good to excellent technical writing skills and verbal communication skills.
• Excels in a fast‑paced team environment, handles multiple tasks concurrently, and completes them timely.
• Highly self‑motivated and goal‑oriented.
• Will support and demonstrate quality standards to ensure data of highest quality.

• Experience in a small company and high‑growth, fast‑paced environment.
• Experience working with additional electronic laboratory systems such as ERP, BMRAM, Empower, LabX.
• Experience with instrument integration/direct data capture from stand‑alone COTS systems to LIMS application.