P.E.
Project Design & Management Consultant - Arthur T. Chakalis, Inc
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PROFILE:
Project Management | Design Engineering | Deploying New Technologies in Multi-Site / Global Environments
Quality-focused process and project engineering manager with substantial and diversified experience in:
Drug - Infant/Adult Nutritional - Medical Device Manufacturing and Packaging
Demonstrated success collaborating with C-level executives and engineering professionals, as well as skilled trades and production team members to clearly define project objectives and mission-critical planning and benchmarking targets from initial design through implementation in support of budget and revenue goals. Published and patented individual whose management and project leadership strengths include:
o Project Planning and Design Engineering
o Project Implementation and Construction Management
o Project Commissioning, Validation and Startup
o FDA Compliance and Remediation including both Equipment and Software Validation
o Sustain Teamwork under Demanding Technical, Financial and Scheduling Pressures
o Scope of Projects Has Spanned from Thousands of Dollars to $130M
Assimilates and effectively communicates technical information in a pragmatic and common sense manner.
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WORK EXPERIENCE:
Project Design & Management Consultant
Arthur T. Chakalis, Inc. 1996 to Present
Manage project design through implementation as well as the subset of validation efforts on new product introductions and facility expansions. Consultative in a variety of facility planning, manufacturing, packaging, and distribution technologies as well as regulatory compliance for processes and software.
o Validation planning and management on an owner's new process and new product commercialization project. This was a series of aseptic production line projects totaling over $70,000,000. Retained when the client's schedule was not being achieved on the first phase of the program. Ultimately, the planned completion
of the FDA filing and internal validation requirements were achieved.
o Manufacturing/Packaging Engineering/Distribution support on a variety of projects covering production line/package debugging, FDA validation, startup, and package/equipment performance evaluation. Technologies span primary and secondary packaging including RFID track-n-trace, powder drying, powder and liquid filling, traditional retorted liquid through state of the art aseptic process and filling systems.
o FDA Compliance Remediation including 21 CFR Part 11 software for quality systems and process control as well as manufacturing, packaging and test equipment assessment and revalidation.
AdaptS Easily to New Environments Including Cross-Cultural Management and Diplomacy Styles. Sampling of Clients: Abbott, Boehringer Ingelheim, Boston Scientific, Covance, and Zimmer
Project Manager
Ventura Engineering 1992 to 1996
Oversaw management of engineering design and performance of project engineering consulting services for
various industrial or manufacturing based clients.
o Project Engineer on an owner's fast track aseptic processing project that was not meeting the required timetable. Developed a comprehensive plan and managed the final design, facility construction, equipment installation, qualification, FDA validation, and startup activities to achieve the original project timetable.
o Validation Manager on an owner's new product production line project. This was a major capital project totaling over $50,000,000. Coordinated the completion of the engineering qualifications and the entire validation effort needed for both FDA compliance and the owner's internal validation requirements.
Project Manager
The Limited 1990 to 1992
Led distribution center planning, design and project implementation. Managed a major portion of 12 vendors'
designs and installation of a $130,000,000 distribution complex to accomplish the on time scheduled startup.
Planned and directed all aspects of project implementation for two high growth division's distribution facilities.
Project Manager
Ross Laboratories Division of Abbott Laboratories 1979 to 1990
Project Manager (1982-1990); Staff Industrial Engineer (1979-1982) Responsible Responsible for managing projects from concept throu...
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