- Syner-G BioPharma Group (Boston, MA)
- …valued, and your contributions make a meaningful impact. For more information , visit www.Synergbiopharma.com (Syner-G is seeking both Process and Validation ... commissioning and qualification of facilities, utilities, and equipment (FUE).Assist with risk assessments, feasibility reviews, risk mitigations, and testing of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Real Estate; Digital, Data and IT; Finance and Tax) and complex and high- risk supplier contracting. Relationships This job reports to the Managing Assistant General ... contracting and recommend best practices and solutions Proactively conduct comprehensive risk assessments to identify potential legal and operational risks within… more
- Merck & Co. (Durham, NC)
- …troubleshooting aseptic formulation and filling processing operationsFamiliarity with process risk assessment tools, Quality by Design principles, and Lean/Six Sigma ... Product Formulation, Quality Assurance Processes, Quality Operations, Regulatory Submissions, Risk Assessments, Risk Control Assessment, Standard Operating… more
- Merck & Co. (Durham, NC)
- …technical documents to support regulatory filings including technical reports and risk assessmentsAuthor or approve Change Control documentation for complex process, ... and Instrumentation DiagramsLean Six Sigma belt certificationExperience with process risk assessment toolsExperience with responding to regulatory questions with… more
- Merck & Co. (Rahway, NJ)
- …manufacturing process development, qualification, and validation; and design control and risk management techniques to positively support and influence clinical and ... design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the interdependent deliverables for MES and/or digital projects and ensures that quality, risk , cost, time are managed within the overall approved plan to drive ... criteria for the project.Develops options and solutions to complex project risk problems, providing guidance to leadership including trade-off and implications… more
- ValSource, Inc. (Rahway, NJ)
- …projects simultaneously. Strong understanding of EPCMV, Quality by Design and risk -and science-based approaches for compliance are desired. Experience with system ... and process risk assessments; including FMEA, HAZOP and Fault Tree Analysis...related technical degree and combined relevant industry experience. Other information This is a full-time position with ValSource. As… more
- Merck & Co. (Rahway, NJ)
- …as system development lifecycle (SDLC), assessments of data integrity, privacy, risk , and other aspects necessary for GxP useImplement automation solutions, ... CAPAs. Position Qualifications: Education Minimum Requirement: -Bachelor's degree in information technology, Engineering, Scientific, or related field Required Experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …certification program to ensure adequate qualification of auditors per regulatory expectations. Risk Management and Vendor Performance: Responsible to ensure the ... risk management activities completion for vendors and to periodically...with local procedures and standards. Accountable to track this information on QA electronic system and to communicate to… more
- Merck & Co. (Rahway, NJ)
- …with application of Lean Six Sigma principles, as well as Risk Management tools.Understanding of new product introduction, commercial supply, lifecycle ... Packaging Engineering, Process Optimization, Product Packaging Design, Project Leadership, Risk Management, Root Cause Analysis (RCA), Technical Leadership, Technical… more
