Empower CDS LIMS Consultant

Job Description: 

• Act as a primary point of contact for Empower CDS support, build and consulting for multiple operating companies across multiple geographies.
• Coordinate with the various stakeholders (TCS support team at different locations, client delivery managers & IT staff, and non-technical end users) to understand requirements/problems/issues and provide solution.
• Authoring and review of validation Documentation for multiple laboratory platforms.
• Should be also able to take responsibility with application support for any number of applications within the lab portfolio covering multiple functionalities.

Technical Responsibilities:

• Understand architecture of client's Empower Enterprise system setup and their impact on the overall functioning of the systems.
• Complete ownership of Empower upgrades involving upgrade to higher versions, legacy version decommissioning, DAC and system configurations, User management etc.
• Development and validation of custom fields and report methods within Empower CDS.
• Understanding of Empower LIMs (Labware, lab vantage) interface and SSQT tool.
• Provide technical infrastructure planning and implementation services.
• Provide technical solution scoping and proposal development.
• Overall understanding of architecture of an analytical laboratory, the application process flow, and the overall interdependence across applications

Must Have Technical Qualifications:

• Strong concepts on fundamentals of Chromatography (Gas, Liquid and components in a chromatography system e.g., mobile phase, stationary phase, solvent, solute, sample, detector, column etc.)
• Enterprise Empower system architecture encompassing different geographies, using Citrix server and centralized database model.
• Empower3 configuration and administration
• User Management (LDAP, User types, User roles) 
• Empower project management (Create, Back-up, Restore projects, Clone, View Metadata, Raw data, Move Project Data, Lock, Unlock)
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• System/Node management (Add instrument components, use of DHCP, Serial Ports, USB etc., Access, DAC release, DAC Build, add new chromatographic system etc.)
• Audit Trail (Effective use to filter out events and use that for troubleshooting of complex issues, Generate reports etc.)
• Escalation to application vendor with respect to issues/requirements that cannot be handled through immediate investigation.
• Capability of interpretation of Empower Message Center
• Back-up/Restore Project data and audit trails.
• License Management and deploy new licenses.
• Complete knowledge on interfaces like IEEE-488, Ethernet, Equinox, COM, Serial, e-SATIN, and ability to troubleshoot connectivity issues. Knowledge of Networks (LAN/WAN), Servers.
• HPLC/UPLC/GC principles of operation, Calibration, Firmware installation and controlling those through Empower (focus on Agilent 1100, 1260, 1290, Waters UPLC, Beckman Coulter using e-SATIN, Shimadzu instrument configurations etc.)
• Familiarity with Quick Start, Pro and Walk-Up interfaces
• ICOP/ICS installation
• Data Acquisition and processing (Integration methods – Apex Track and Traditional, concepts on shoulders, peaks, retention time, Lift Off %, Touchdown %, Gaussian skim, Valley-to- Valley)
• Custom Field and Report Method development
• Root Cause Analysis covering all aspects of Lab informatics and Empower.

Must Have Business Qualifications:

• Working on Proposals, Estimation and Presentations
• Should have worked in regulatory environment (USFDA, UKMHRA) with understanding of relevant ICH guidelines and 21 CFR Part 11 compliance.
• Should perform validation (IQ/OQ/PQ) for Empower and LAC/E
• Risk Management, Project management, lead, and own deliverables without much supervision
• Client Management
• Acting as SPOC and coordinating with Business, Business IT, Delivery Managers
• Ability to groom and manage a dedicated team of 5 to 6 members.

Nice to Have Qualifications:

• An exposure to LIMS and SDMS is desirable.
• Proven ability to lead and manage a team of 5-6 consultants.
• Scientific Data Migration Knowledge is desirable.
• Complete knowledge on HP ALM and GXP validation
• Knowledge of PL/SQL is desirable.