We are looking for a new colleague for a Chromatography Software SME position for our pharmaceutical clients own team. With sufficient exposure to Lab processes and software skills in Empower, Empower SME implements/upgrades application and supports users who are using Empower application in their labs. He works in approved Empower projects as part of Project team in configuring, adding/modifying scripts and creating templates/reports. He helps functional team in sorting out any issues/escalations related to technical aspects, trouble shooting in instrument/communication related errors and gaps. Empower being an important application which controls chromatographic instruments, data acquisition, reporting, compliance, data integrity and productivity in lab operations, SME ensures continuous upkeep and improvements of Lab operations by his system support.
- Handles implementation & upgrade projects of Empower for GxP laboratories
- Deploys/Installs Empower in server, Citrix servers, processing clients and LACe when required
- Manages Installation of OS Software, Oracle DB, Drivers in client/Citrix, instrument firmware along with respective SMEs
- Supports Lab teams during Regulatory audits for any technical help/explanations when necessary
- Has good knowledge/exposure in Empower 3. (or other similar system)
- Understands Waters release notes and other documents related to instruments from vendors to identify compatibility of drivers/firmware required to install/upgrade LacE boxes and instruments
- Possesses complete knowledge on user privileges, policies of Empower, instrument configuration and project setup
- Coordinate with multiple instrument vendor (E.g. Waters, Agilent, Thermo Fischer, Perkin, Shimadzu, etc.) during application/instrument setup and instrument qualification
- Works with lab team to setup custom field/calculation & report methods and ensure all required validation/compliance and controls are in place
- Handles Empower-LIMS integration for bi-directional data transfer
- Has Knowledge in Developing and reviewing of SOPs / Work Instructions, training modules/materials and Validation documentation such as Validation Assessment/Approach, risk assessment, Protocols, Summary Reports, and IQ/OQ/PQs
- Sound understating of Regulatory Compliance, Quality, Data Integrity, CAPA, Change Management processes in highly regulated environments
- Identifies and implements process improvement opportunities, cost improvement and monitor the effectiveness of the such improvements.
- Handles escalations related to product functionalities which could not be solved by designated Lab SMEs or Run team
- Plays his assigned technical role effectively during new project implementations, roll-outs, enhancements, etc.
- Thinks proactively where improvements are needed in the system, brings them for discussion with Leads and follow through till effective
Good to have
- Exposure to Chromeleon is an added advantage
- Certification of Empower Admin is preferred
- Really competitive salaries, benefits
- Inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.