Biopharmaceutical IT Specialist

Job Description:

The successful candidate will have ownership and administration of the IS aspects of Lab equipment, including analytical equipment platform architecture, system ownership, and lifecycle management.

This role will provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and QC analytical personnel.

The ideal candidate will lead and support system improvements, development of detailed specification, and standard operating procedures. They will also ensure reliable, consistent & compliant operation of Lab Equipment Instruments to meet the GMP and business requirements of the labs.

This position involves technical root cause analysis, incident investigations, and troubleshooting issues related to the Quality and Laboratory information systems.

Requirements include experience with LIMS and Empower, knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable in relation to Lab IT requirements.

The successful candidate must have at least 3 years' experience supporting Quality and/or Laboratory information systems in the biotechnology or pharmaceutical industries or has worked in similar Laboratory environments and has gained expertise in the use of Laboratory information systems.