Sr. Validation Consultant
BearingPoint is a leading management and technology consulting company serving the Forbes Global 2000 and many of the worlds largest public services organizations. Our more than 17,000 passionate, experienced consultants help organizations around the world solve their most pressing challenges, day in and day out. Through our collaborative and flexible approach, we deliver practical, sustainable, measurable results that help our clients make the right strategic decisions and implement the right solutions.- This resource will provide subject matter expertise in validation and FDA compliance, in order to support of the implementation of PLM, LIMS, MES, and/or ERP. The resource will manage project deliverables and maintain the validation project plan throughout the implementation.- Top performing team members are capable of contributing to the implementation process beginning with the development of information harmonization and common information models for product information for strategy and design. Top performers have a good understanding of the data needs for management systems and processes that are typically employed by Life Sciences companies. - This resource will normally be involved from the Strategy phase through implementation and would normally be expected to perform as a compliance manager for implementation technical tracks, as subject matter expert on regulatory concerns and restructuring the clients software development lifecycle information.- This resource must be viewed as an expert within GxP Compliance and CSV Methodologies by our clients, and by the BearingPoint client engagement teams.- This resources, in addition to expertise in Validation and compliance, must have a secondary skill in either LIMS, SLM, MES, or ERP.Position-specific Requirements: -Technical and functional requirements: Experience working in Life Sciences in the area of validation or GxP compliance. Ideally the candidate would have working knowledge of LIMS, SLM and MES applications, and product information management processes. The successful candidate must have experience with the ERP applications, such as SAP or Oracle. Direct experience in life sciences with enterprise applications supporting supply chain operations (e.g.; ERP, EDMS, PLM, MES, LIMS, and regulatory publication systems) is strongly desired. 100% travel required for role.-Knowledge/ experience of performing compliance audits is a plusBearingPoint is an Equal Opportunity Employer and does not discriminate on the basis of race, national origin, religion, color, gender, sexual orientation, age, non-disqualifying physical or mental disability or any other basis covered by law. Employment decisions are based solely on qualifications and business need. We are BearingPoint, a global management and technology consulting company known for our deep industry experience and high customer satisfaction. We collaborate with clients in government and industry in 60 countries to solve their most pressing challenges from strategy through execution. Our more than 17,000 employees provide strategic consulting, applications services, technology solutions and managed services to government organizations, Global 2000 companies and medium-sized businesses in the U.S. and around the world. Our service offerings are designed to help our clients generate revenue, increase cost-effectiveness, manage regulatory compliance, integrate information and transition to "next-generation" technology. We earn recognition for our client service from leading analysts and trade publications but are proudest of our high customer satisfaction scores. We're looking for a special kind of candidate. We're searching for something different. Are You? See why BearingPoint might be the best career choice for you. View the video. Job Title: Sr. Validation Consultant Company: BearingPoint Location: Warren Status: Full Time Job Category: Business/Strategic Management
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