General requirements:
Able to provide LIMS technical support in a GMP regulated environment. General working knowledge of laboratory testing processes and documentation. The role requires troubleshooting and communication skills, initiative, determination and responsibility.
Responsibilities include but not limited to:
- Manage and complete all Support tickets in a timely manner related to troubleshooting at the application level, errors, user configuration, user creation, deletion.
- Work directly with level 3 administrators to resolve any issues/requests escalated to the Level 3 team.
- Contribute to the support and maintenance of operating procedures (SOPs and Work Instructions) pertaining to LIMS by reviewing updates to documents as requested by the validation lead/system manager.
- During LIMS upgrades and/or enhancements, perform development testing and support user acceptance testing, and upgrades.
- Identify opportunities for improving LIMS functionality and performance and provide recommendations to the system manager.
- Identify opportunities for streamlining LIMS business processes to improve efficiency and compliance and provide recommendations to the system manager.
- Maintain the LIMS system in a state of GMP compliance to ensure data integrity by following all related SOPs as they pertain to support duties.
- Perform LIMS maintenance tasks including:Account maintenance, periodic review of account and System Audit Trail and server maintenance.
1. As a Support Engineer, provide support with LIMS system in GxP environment.
2. Experience in service desk tools such as ServiceNow.
3. Experience in Citrix Receiver, XenApp platforms.
4. Good understanding of Active Directory, SharePoint.
5. Take ownership of incidents and service requests and work to resolve them to user satisfaction while adhering service-level agreements.
6. Regularly compile and provide metrics on incidents and service requests, trends to management.
7. Skills:
a. Good understanding of Laboratory Informatics Systems and business processes.
b. Excellent verbal and written communication skills.
c. Experience working in Pharmaceutical RD, QC laboratories is a plus.
Mandatory Knowledge, Experience and Skills:
Fluency in English language both written and oral is imperative
Excellent communication skills with the ability to support clients remotely
Good understanding of PC hardware and use of Windows and Microsoft office including Excel
Bachelor’s degree in Science for Chemistry, biology or physics or a mathematical subject.
5. 1 - 3 years’ experience using the functionality of at least one of the Lab Information Systems such as Empower, LIMS, BIOVIA LES, Veeva Vault in the pharmaceutical or related industry.
Preferred Experience
Ø Experience in Quality Control laboratory environment.Good working knowledge of laboratory testing processes and automation using various instrument software packages. Including the understanding of analytical chemistry and instrumental analysis. Displayed hands-on proficiency and problem-solving skills with chromatographic techniques.
Ø Certification or Knowledge of Current Good Manufacturing Practice, FDA 21 CFR Part 11, and EMA EU GMP Annex 11: Computerized systems
Ø Understanding and certifications of ITIL framework
Ø Microsoft Windows software and network certifications
Ø Experience in adhering to System Support KPIs
