Job Title: Laboratory Systems IT Engineer
This role involves the ownership and administration of IS aspects of Lab equipment, including analytical equipment platform architecture, system ownership, and lifecycle management. The successful candidate 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.
* Lead and support system improvements, development of detailed specification, and standard operating procedures.
* Ensure reliable, consistent & compliant operation of Lab Equipment Instruments to meet the GMP and business requirements of the labs.
* Lead technical root cause analysis, incident investigations, and troubleshooting issues related to the Quality and Laboratory information systems.
Required Skills and Qualifications:
* Experience with LIMS and Empower is desirable.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable in relation to Lab IT requirements.
* 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.
Benefits:
* University degree in related science/IT/quality discipline required.
* Ability to master, with minimal support, new IS technologies and processes.
* Strong knowledge of databases, reporting, and analytic systems.
Others: