Job Description
The engineer will provide Support for Empower 3.8 in a GMP regulated environment globally, applying knowledge of current Good Laboratory practices. They will have knowledge of Service Now or similar ticketing system. They will provide site administration, by writing and executes protocols and reports. They will create and manage Empower projects, users, Instrument Methods, Method Sets, report methods and processing templates. Additionally, they will troubleshoot instrument connectivity issues, custom field calculations and optimizing processing methods.
Job Responsibilities
Provide administration and technical support to Empower in a GMP regulated environment.
Perform Empower system administration maintenance tasks including: project creation, archive and restore, audit trail review, and account maintenance, while following all applicable Gilead SOPs and work instructions.
Complete assigned tickets associated with Empower system incidents in the timeframe dictated by the ticketing system.
Familiarity with Method Validation Manager in Empower, able to assist users with troubleshooting/errors.
Troubleshoot instrument connectivity issues, custom field calculations, rebooting LACEs, and optimizing processing methods.
Provide technical expertise in identifying, evaluating, and developing Empower and procedures that leverage system capabilities and meets user requirements.
Contribute to the support and maintenance of validation package as it pertains to Empower: URS, FRS, SDS, TM, and report specifications.
Identifying opportunities for streamlining Empower business process and performance issues by working with other system administrators and end users to help configure and develop Empower functions based on business requirements.
For Empower upgrades and/or enhancements, perform development testing and support user acceptance testing.
Industry Experience
Using the functionality of Empower in the pharmaceutical, biotechnology for minimum of 3 years’ experience in Empower Superuser/Administrator role.
Experience with Empower interface to other lab software systems such as LIMS an advantage.
Good working knowledge of laboratory testing processes and automation using Empower 2/3, such as but not limited to: HPLC – Dissolution/Impurity/Assay Analysis and GC. .
Solid understanding of analytical chemistry and instrumental analysis. Hands-on proficiency and problem-solving skills with chromatographic techniques such as but not limited to HPLC and GC.
Customer satisfaction and job behaviours required
Excellent verbal and written communication skills.
Supporting end user system needs
Trouble shooting all aspects of using Empower by end users.
Strong analytical, problem-solving and technical skills to develop practical solutions to business problems.
Skills, training, education
Bachelor’s Degree in Science
Waters Empower administrator training
Preferred qualification in GAMP5 or Computer Systems Validation
Working knowledge and proficiency with Microsoft Office software