Merck Sharp and Dohme LLC seeks

Specialist, Laboratory Automation/IT (Elkton, VA) to w

ork within the Laboratory Automation and IT group to transform the organization into an integrated and efficient organization that connects lab data, processes, systems, and instruments with enhanced digital capabilities and compliance. Participate in validation engineering projects from start-to-finish. Serve as a computerization validation specialist for new or upgraded laboratory instruments. Participate in writing system requirements. Configure the system software for the laboratory instruments for the specific working environment. Develop software testing scripts to verify requirements are met. Communicate with instrument end-use experts (chemist, biologist, engineer, etc.) to understand desired functionality of systems. Determine best process and system configuration to meet business functions. Ensure configuration meets company compliance requirements and specifications. Translate user requirements and compliance requirements into technical specifications for new or upgraded laboratory instruments. Develop value added system solutions. Develop testing steps to verify solution meets requirements. Write standard operating procedures for administration and/or software use of computerized systems. Work with groups from internal laboratories and/or work teams, other IT technical support teams, and corporate governing teams. Provide expert support to lab system users. Provide documentation/technical input during inspections and audits (Regulatory and Internal). Identify and leverage opportunities to continually improve the quality and effectiveness of lab systems, data management systems, processes, and standards. Participate in the design of the processes, and the implementation of data integrity improvements. Support change management for data integrity and participate in maintaining a strong data integrity culture.

LOCATION:

Merck Sharp and Dohme LLC, 2778 S E Side Highway, Elkton, VA 22827

REQUIREMENTS:

Master's degree or equivalent in Computer Science, Science, Engineering, Biotechnology or related discipline and 3 years of experience in the offered role or a related occupation. Requires 3 years of experience with all of the following: System Developmental Life Cycle (SDLC) in the pharmaceutical industry; incident management, root cause analysis and corrective action plan; performing assessments of computerized/non-computerized systems with knowledge of the latest specifics of data integrity and compliance as it relates to original electronic data completeness, consistency and accuracy, as focused from global pharmaceutical regulatory agencies; BioTek Microplate reader, Agilent UV-Vis Spectrophotometer, Applied Biosystems 3500xL Genetic Analyzer, Applied biosystems Real-Time PCR System, Bio-Rad Densitometer, Wyatt DynaPro Dynamics Light Scattering System, Computer controlled Eppendorf Liquid Handling System, Computer controlled Hamilton MicroLab Liquid Handling System, Thermo Fisher Nicolet FTIR Spectrometer, Molecular Devices Microplate Reader, Rudolph Polarimeter, Sievers Total Organic Carbon (TOC) Analyzer and VERITI multi-well Thermal Cycler; system configuration, data integrity (DI) assessment, and development and implementation of technical solutions for DI gaps, and administration of the following: Charles River EndoSafe EndoScan-V, Image Lab, Applied Biosystems MicroSEQ ID, Applied Biosystems Data Collection software, Wyatt Dynamics, Eppendorf epBlue, Molecular Devices SoftMax Pro GxP, Molecular Devices GxP Admin, Hamilton Run Control V., Thermo Fisher OMNIC, AccuSEQ Real-Time PCR Detection, Agilent Cary UV Workstation, and Agilent Control Panel for Open Lab Software; antibiotic containment principles, Pharmaceutical Laboratory Business and Manufacturing Operations; McAfee Application control, SAP, and MS tools (Word, Excel, PowerPoint, OneNote, SharePoint, Teams); training laboratory specialists (chemi ts, biologists, engineers, and related) on system operations; and Electronic Data Management Systems (EDMS) including importing/exporting documents, routing documents for review and/or approval cycle, and document rendition. 5% domestic and international travel required.

SUBMIT RESUME OR CONTACT:

[Apply at https://jobs.merck.com/us/en. Reference job #[R276352.[]{#_Hlk145664499} ]{calibri",sans-serif"=""}]{calibri",sans-serif"=""}