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Senior project lead
Job Description
Senior project lead
Job Summary
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Location: New Jersey
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Project role: Senior project lead
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Qualification: B-Tech
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Experience: 5-7 Years
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Skills: Life Sciences_Manufacturing
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No. of positions: 1
Job description:
MES SpecialistPreferred Skills: Bachelor s Degree or Higher 5+ years of professional experience in the MES product knowledge, Pharmaceutical validation concepts and documentation, Pharmaceutical business process domain knowledge cGMP and GDP standards and GAMP Standards Hands-on experience in WERUM MES (PAS-X) application with extensive implementation skills. MES product knowledge, Pharmaceutical validation concepts and documentation, Pharmaceutical business process domain knowledge cGMP and GDP standards and GAMP Standards Good understanding in communication of MES and SAP/other interfacing automation components. Application knowledge in JBoss server functionality and MES Print functionalities. MBR Designing, MES to SAP, MES to Automation interface knowledge Create business process flow diagram for pharmaceutical product recipes based on the paper batch record. Gather MES Site specific requirement analysis to develop URS and FRS. Logically breakdown the recipes. Mfg. process following standards Procedure Unit procedures Operations phases to configure the recipe in to Werum MES (PAS-X). Good written and verbal communication skills to effectively communicate with technical and business users. Knowledge in GxP terms as per 21 CFR PART 11, Compliance issues and Documentation. Nice to have a Pharmaceutical domain expertise. Experience identifying operational issues and recommending and implementing strategies to resolve problems Proficiency in German language Job Roles/Responsibilities: Develop create MBR design elements building blocks and workflows in Werum MES (PAS-X) for repetitive use in MBR creation to expedite the process. Gather master data and configure upload in Werum MES (PAS-X) Environment & Integrating Werum PAS X with SAP and other automated systems using standard interface. Execution of change requests for support and any enhancements as required. Update MES documents such as DS, SOP, IQ Protocols as needed for tickets resolutions or any enhancements as required. Configuration of system data work centers scales, barcode scanners and printers. Lead the recipe design session with business process SMEs & Design MBR recipe equipment workflow status diagram based on the Business process flow. Coordinate and support with respective groups/departments and vendors for implementation or hyper care activities after patch or system upgrades. Configuration for the impacted components and interfaces including JBOSS, WXI, Scales, and Printers Attend periodic review meetings, cutover migration, hyper care support, any enhancements planning, design and/or implementation meetings as required. Good at customer handling and liaising with all stakeholders.
Disclaimer
HCL is an equal opportunity employer, committed to providing equal employment opportunities to all applicants and employees regardless of race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical disability or genetic information, military or veteran status, or any other protected classification, in accordance with federal, state, and/or local law. Should any applicant have concerns about discrimination in the hiring process, they should provide a detailed report of those concerns to secure@hcl.com for investigation.