- Merck & Co. (Rahway, NJ)
- …and SOPs for all GxP automation systems.Lead integration of control systems with MES , Quality, and Batch Reporting applications.Understand and adhere to CFR, ... Provide key automation support for various manufacturing systems such as PLC, MES , SCADA, DCS, and OEM systems-Work with process development teams on technical… more
- Merck & Co. (Durham, NC)
- …Experience with Deviation Management. Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records ( MES ), Trackwise and GLIMS. RCA (Root Cause ... with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations, critical site review, critical… more
- Merck & Co. (Rahway, NJ)
- …Good Manufacturing Practices (GMP), Laboratory Techniques, Manufacturing Quality Control, Master Batch Records , Material Selection, Pharmaceutical ... an electronic system.- Knowledge of PAS-X is preferable.GMP: Follow established inspection batch records , protocols and quality standards to ensure compliance… more
- Lilly (Indianapolis, IN)
- …(eg, GAMP 5, 21 CFR Part 11, Annex 11). + Experience authoring and validating Master Batch Records (MBRs) in a regulated environment. + Strong documentation ... + Ability to interpret process requirements and translate them into MES configurations or electronic batch records . + Strong troubleshooting skills, with the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Manufacturing production + Experience with platforms critical to Biologics Clinical Manufacturing (eg, MES / Electronic Batch Records , ERP Mfg, CMMS, Digital ... deadlines in a complex matrix organization + Proven track record of critical thinking, analytical ability, operational excellence, and...degree and 5+ years of relevant experience; OR + Masters ' degree and 3+ years of relevant experience +… more
- Merck (Rahway, NJ)
- …SOPs for all GxP automation systems. + Lead integration of control systems with MES , Quality, and Batch Reporting applications. + Understand and adhere to CFR, ... automation support for various manufacturing systems such as PLC, MES , SCADA, DCS, and OEM systems + Work with...with minimum of 4 years relevant experience, or a master 's degree with minimum years of relevant experience. **Preferred… more
- Regeneron Pharmaceuticals (Troy, NY)
- …Manage complex validation requirements and change control processes while transforming paper-based batch records into compliant digital workflows. + Diagnose and ... The Director of MES (Implementation and Integration) will drive the end-to-end...you have: + Comprehensive understanding of biopharmaceutical manufacturing processes, batch record requirements, validation standards, and change… more
- Lilly (Indianapolis, IN)
- …you'll work in a growing organization to help design and develop new electronic Master Batch Records (MBRs) using our Next Generation Manufacturing Execution ... site reliability engineering, or disaster recovery. + Consistent track record in tools / platforms such as MES... record in tools / platforms such as MES (PMX, PharmaSuite, and/or Syncade) as well as WES/SAP,… more
- Cognizant (Sacramento, CA)
- …are seeking an experienced MES Werum PAS-X Specialist to support Electronic Batch Record (EBR) implementation for a leading pharmaceutical client. The role ... EBR implementation. + Design and develop State Diagrams and update Master Data within MES . + Configure, customize, install, upgrade, and develop Werum PAS-X… more
- Capgemini (Raritan, NJ)
- …**KEY RESPONSIBILITIES** **:** Job Scope And Responsibilities Requirements: Manufacturing Electronic Batch Record (EBR) generation using PAS-X () Hands-on ... WXI) PAS-X Front End configuration/administration experience (Users, profiles, scales, printers, master data admin ) Windows servers basic troubleshooting Data Base… more
- Capgemini (Fort Washington, PA)
- …PAS-X) and other pharmaceutical automation systems. + Must have knowledge of PMBR (Parameter Master Batch Records ) and PVL (Parameter Value Language) + Must ... Must have Bachelor's degree in engineering, Computer Science, or a related field. + Masters degree is a plus. **Life at Capgemini** Capgemini supports all aspects of… more
- Merck (Durham, NC)
- …Experience with Deviation Management. + Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records ( MES ), Trackwise and GLIMS. + RCA (Root Cause ... with cGMP, regulations, and our Company's Quality Management System focusing on batch record review, process/aseptic observations, critical site review, critical… more
- Merck (West Point, PA)
- …EBRs in PAS-X and the new EBR system (for Clinical Bulk Manufacturing), including master batch record development, parameters, phases, and workflows. + ... the Project Manager will own project planning, delivery and sustainment for MES /EBR (Manufacturing Execution System/Electronic Batch Record ) initiatives.… more
- Mentor Technical Group (Juncos, PR)
- …in electronic systems for instance: Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record ( MES ) and SAP. + Experience with ... Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and… more
- Global Foundries (Austin, TX)
- …Lead with a strong background in the semiconductor and high-tech industries, MES integration, and Big 4 consulting experience. The ideal candidate will possess ... extensive SAP certification and a proven track record in leading SAP S/4HANA and EWM/TM implementations. Essential Responsibilities: + Project Leadership: Lead the… more
- Merck (Rahway, NJ)
- …Good Manufacturing Practices (GMP), Laboratory Techniques, Manufacturing Quality Control, Master Batch Records , Material Selection, Pharmaceutical ... system. Knowledge of PAS-X is preferable. + GMP: Follow established inspection batch records , protocols and quality standards to ensure compliance with… more
- ITW (Troy, MI)
- …& returnable packaging) + Experience with BOMs, routings, production scheduling, and MES integration + Track record in SAP transformation projects including ... management in an automotive supplier environment. You will: + Implement Batch Traceability, Production Scheduling and Production Execution processes + Support… more
- Mentor Technical Group (Juncos, PR)
- …South America. Responsibilities: + Quality Professional with Manufacturing Process Audit and Batch Record Review experience. + Available for non-standard shifts ... nights and weekends. + Basic knowledge of the process, PASx/ MES application, MAXIMO, SAP, and LIMS. Education & Qualifications...degree and 5 years of directly related experience or Master 's degree and 3 years of directly related experience.… more
