Pharma/Biotech Manufacturing Consultant

BearingPoint’s Life Sciences Supply Chain Solution Team is currently seeking a qualified individual(s) to fill an immediate need to provide our existing pharmaceutical clients with leadership, strategy, and execution of information standardization and harmonization. This role will report to a manager / senior manager in the life sciences group focusing on manufacturing strategy and implementation. In this role, the candidate would provide subject matter expertise in the planning and implementation of manufacturing focused systems.
The candidate should have knowledge of business process and data modeling based on standards utilized in manufacturing (ISA-S88, ISA-S95, OPC).
This resource will provide subject matter expertise with design and implementation of manufacturing solutions for clients including CMMS, MRP, MES, LIMS, SCADA, DCS, CAPA. This resource has experience in lean manufacturing and six sigma experience in applying to manufacturing operational excellence. This resource can help establish KPI’s and best practices around the plant operations. Six Sigma Green Belt / Black belt certification a plus. Top performing team members are capable of contributing to the best practices of MES, CMMS, LIMS, and MRP implementation process. This includes plant optimization, process control knowledge. This resource will normally be involved from the strategy phase through implementation and would normally be expected to perform as a project manager for implementation business and technical tracks, plus function as subject matter expert on MES/CMMS and understanding the integration into other components of the supply chain. Project Management, Change Management, or Vertical Start-up Management experience a plus. During the strategy phase of Plant Operations engagements, this resource should present ideas, suggestions, and recommendations beyond those already in place for implementation technology and integrations to other ERP components such as SAP, JDEdwards, or Oracle.Position-specific Requirements:

Technical and functional requirements: Experience working in Life Sciences in manufacturing and material management business processes. Implemented MES solutions such as Werum, Honeywell, Propak, Camstar, DMI or DataStream. Working knowledge of Product Development, Technology Transfer and Product Registration processes.
Ideally the candidate would have working knowledge and experience in MRP (such systems as: SAP, JDEdwards, Oracle, Prism, AMAPS, BPCS) Applications, product information design, and product information management processes. APICS certification is a plus.
Working knowledge of Computer System Validation and System Development Life Cycle methodology and FDA regulations 21 CFR 11, 210, 211, 600, 610 and 820.

Minimum years of Life Science experience required: 10 years -Minimum Manufacturing / Engineering experience required: 4 years -Engineering / Technical degree strongly preferred.

Travel requirement: Average 70%
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