Empower Systems Analyst
Perm - Cork
- Provide Empower 3.0 technical support in a GMP regulated environment globally.
- Applies knowledge of current Good Manufacturing Practices (cGMPs) and Good Laboratory practices
- Working knowledge and proficiency with Microsoft Office software
- Writes and executes protocols and reports
- Provide Empower technical support for Cork site.
- Supporting end user system needs
- Creating, reviewing, and locking Empower Instrument Methods, Method Sets and processing templates.
- Trouble shooting all aspects of using Empower by end users.
- Trouble shooting instrument connectivity issues, custom field calculations, rebooting LACEs, and optimizing processing methods.
- Good working knowledge of laboratory testing processes and automation using Empower. Knowledge includes but not limited to: Fraction Collection, Mass Spec, Dissolution, Multi-Component analysis, Labware LIMS interface, and NuGenesis SDMS.
- Minimum 6 years' experience using the functionality of Empower in the pharmaceutical, biotechnology, or other related industry or minimum of 3 years' experience in Empower Administration.
- Experience using NuGenesis SDMS and Labware LIMS preferred.
- Experience in Quality Control laboratory environment preferred.
- Solid understanding of analytical chemistry and instrumental analysis. Hands-on proficiency and problem-solving skills with HPLC, GC, LC-MS and other chromatographic techniques. Familiarity with spectroscopic techniques is an advantage.
- Strong analytical, problem-solving and technical skills to develop practical solutions to business problems.
- Good working knowledge of laboratory testing processes and automation using various instrument software packages.
- Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), service management, IT project lifecycle and other regulatory requirements or policies
- Excellent verbal and written communication skills. Ability to work successfully independently and as part of a group. Ability to communicate effectively with technical and non-technical audiences.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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