Michael Berkey Email & Phone Number

Elkton, Va, Us

Lead strategic site projects from initiation through realization. Assemble and lead multidisciplinary teams to deliver projects that add value and achieve the site master plan. Represent stakeholders and their needs, including business, technical, and compliance requirements. Manage scope, risk, resources, and tasks to attain project goals. Coach stakeholders and team members on the capital management process.Key Projects:* Facility and Utilities Engineering Lead, Manufacturing facility renovation

Reliability and Maintenance leader for the design, implementation, and realization of a new, brownfield production facility. Championed Design for Reliability and Asset Life Cycle approaches for new equipment assets. Led the strategy, planning, and implementation of asset, maintenance, and MRO spare parts management within the CMMS (e.g. SAP), in preparation for facility turnover and operation. Directed the development of complex standards, technical procedures, documentation, and best practices to meet maintenance, reliability, and regulatory requirements. Created a new maintenance team to support facility start-up and the transition to production operations.

Asset Management and Reliability leader, integrating maintenance workflows and CMMS (SAP) with equipment reliability and Asset Management principles. Leading projects and Management System integration (e.g. QMS, PSM, RMP) to provide for GxP, Safety, Environmental, and Financial compliance of the site's Asset Management Program.

Maintenance and Reliability leader in Biologics manufacturing and Laboratory facilities. Facilitated Asset Criticality analysis and asset prioritization for facility, process, laboratory, and utility equipment. Led Reliability-Centered Maintenance (RCM) analysis and the development of maintenance strategies for critical assets, based upon failure analysis (FMEA). Implemented inspections, preventative maintenance, predictive technology, operator care, and vendor service to provide asset availability and equipment performance. Defined the site Calibration Program for manufacturing process instrumentation. Conducted Root Cause Analysis (RCA) of equipment failures and initiated improvements to the application of equipment and maintenance. Developed expertise in SAP Plant Maintenance master data to support development of maintenance strategy, spare parts management, and work execution. Provided reliability review and oversight throughout the lifecycle of assets, from concept through decommissioning.

Quality professional specializing in validation of GMP computer systems, ensuring compliance and consistency with regulatory and industry standards (21 CFR Part 11, GAMP 5, etc.). Provides Automation Compliance program oversight to projects and operations in strategic support of fermentation, API, Aseptic, Solid Dosage, Vaccine, and laboratory facilities.Lead auditor for operational and compliance audits of both internal and external parties. Effectively manages cross-functional audit teams, evaluating management systems from multiple regulatory perspectives (e.g., GMP, EHS, Finance, Trade). Tracks and reports audit program and management system performance in order to facilitate mitigation of business and compliance risks.

GMP Quality control laboratory. Laboratory automation validation, method development, method validation, laboratory system administration, LIMS template development, and analytical testing. Project management and analytical technology transfer for new product introductions.

Mba, Business Administration

Bs, Chemistry, Mathematics