Laboratory IT Systems Administrator Location: Branchburg, NJ Department: Information Te

Job Title: Laboratory IT Systems Administrator

Location: Branchburg, NJ

Department: Information Technology

Reports to: Supervisor Laboratory IT Systems

Job Summary

For systems administration in Pharmaceutical GMP regulated lab areas. Implement, monitor and provide technical support for Hardware, Software and Laboratory applications. Assist in managing the implementation and support of all laboratory systems. Provide ongoing Process Improvement, Risk Assessment and mitigation plans. Create, maintain and enforce Policies, Procedures, Documentation, Validation Plans and Test Scripts in accordance with regulatory standards. Resolve daily hardware and software issues in timely manner.

Essential Functions

Generate, revise, review and execute Validation documents (VMP, URS, SRS, RA, TM, Protocols, Reports, SOPs etc). Perform hardware and software upgrades as needed and generate the necessary documents to maintain the System validated status. Integration of third-party applications and services into the lab environment with knowledge and understanding of Qualification & Validation documentation. Analyze and determine best solutions based on laboratory needs and company goals. Provide recommendations based on best industry practices. Resources should work independently and be able to do decisions under pressure, use negotiation skills to address problems presented in the laboratory.

The Lab System Administrator will provide administration, support and maintenance of Laboratory computer systems and servers as well as support for applications utilized in the lab environment. Requires among others, the following Software Expertise: Empower 3, MassHunter, Specturm ES, UV Probe, Qtegra, Tiamo and Chemstation. Make recommendations about computer and network hardware needs of the laboratory. Analyze vendor solutions and provide feedback aligned with the laboratory and company needs, short and long term. Evaluate impact due to laboratory and equipment software changes maintaining the validated status. Provide end user training of Standard Operating Procedures.

Generate Change controls, Acton plans, Procedures and any other documents related to the Software.

Troubleshoot Network, Server, Client, Printer, Software and Connectivity issues. Analyze, identify & implement enhancements, upgrades and/or solutions to improve the overall support of the desktop platform. in a timely manner

Develop, document, and conduct periodic inventories of client systems while sharing significant knowledge of the operating system, desktop hardware and peripherals, application packaging, desktop tool development, software distribution, and core desktop applications.

Education

Bachelors Degree (BA/BS) in Computer Science, Life Science, or equivalent industry experience - Required

Work Experience

5 years or more - Relevant technical experience including (but not limited to); Windows technologies, networking, backup systems and Laboratory Software's. Must be familiar with Computer System Validation and have knowledge on FDA requirements and 21CFR Part 11. - Required

Skills and Abilities

Ability to: plan, organize and document complex system design activities and to configure systems to be consistent with policies/procedures; - Advanced

Communicate technical/complex information both verbally and in writing; - Advanced

Establish and maintain cooperation, understanding, trust and credibility; - Advanced

Perform multiple tasks concurrently and respond to emergency situations effectively.