Empower CDS

Role: Empower CDS

Location: Pan India

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, labvantage) 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
• Provide technical solution on integration of Empower CDS with other applications using Empower Tool Kit
• Provide technical support in integration of third-party chromatographs and their integration within Empower CDS environment

Relevant Years of Experience: 4-8 years

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)

• 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 CDS

• Knowledge of Empower tool kit and its application

• Knowledge on configuration of third-party chromatographs in Empower CDS environment

• Knowledge on third part driver and ICF/ICS installation including SII for Empower in Empower CDS environment.

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 are desirable and their integration with CDS
• Proven ability to lead and manage a team of 5-6 consultants
• Scientific Data Migration Knowledge is desirable
• Complete knowledge on ALM, qTest and GXP validation
• Knowledge of PL/SQL is desirable
• Sound understanding of SDLC