IS​/IT - Systems Administrator

Job Overview

Job Title: (IS/IT) - Systems Administrator

Location: Westborough, MA 01581

Duration: 12 months

Start Date: Immediate

Pay Rate: $73.33/hr.

The Principle System Administrator will be responsible for defining the requirements for implementation of software systems and managing the requirements for the ongoing operations as the primary interface between Operations and IT. This includes user management, master data configuration, and role management. Primary platforms are LIMS and E  applications. The administrator will support data integrity efforts at the site to ensure compliance to 21

CFR Part 11 for manufacturing and lab equipment.

• Develop and maintain system configuration documentation and plan for new products, equipment, and workflows; provide first line 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, 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; support internal and external audits and collect/report metrics.
• Manage system updates, change controls and maintenance activities as related to systems.
• Troubleshoot issues, solve problems, and assist with investigations and deviations related to software systems.
• Create and manage master data to support existing/new system functionalities.
• Ensure that the integrity and accuracy of all documents are maintained; assess overall document compliance with protocols, SOPs, company policies and applicable regulations.

• B.S. degree in biological sciences, cell biology, chemistry, or related field with 7+ years or M.S. degree with 5+ years of relevant experience in analytical computerized systems.
• Prior laboratory hands‑on experience with a variety of 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 a supportive, 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 in a timely fashion.
• Highly self‑motivated and goal oriented.
• Supports and demonstrates 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.

Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, colour, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.