“PHARMACEUTICAL INDUSTRY - Principal Consultant and Co-founder of Pharma Technology Resources:
Tim Chalmers, Principal Consultant
and Co-founder of Pharma Technology Resources Mr. Chalmers,
Principal Consultant and Co-founder of Pharma Technology Resources, is a pharmaceutical industry professional with a strong
background in manufacturing engineering services and manufacturing regulatory compliance. In his consulting practice, he has
been a key provider of turnkey pharmaceutical engineering services, providing leadership on design, installation, validation,
and training for complex manufacturing systems. His focus in manufacturing regulatory compliance has been the preparation
and assessment of operating procedures and documentation, and preparation for production launch. He has held engineering positions
in equipment design with Shaklee Corporation, a large cosmetic and food supplements company, and in manufacturing engineering
with Syntex Laboratories, a major pharmaceutical company. Mr.
Chalmers has produced FDA compliant standard operating procedures, specifications, and maintenance and manufacturing record
keeping systems. These activities include assessment of current standard operating procedures and their associated documents,
and implementation of procedural upgrades. Clients for these services have included established major pharmaceutical companies
enhancing their regulatory compliance programs as well as for smaller companies whose operations were first entering FDA-regulated
manufacturing. Mr. Chalmers’
compliance activities have also included providing services as validationproject manager and for the preparation of validation
protocols. He has been responsible for preparing and conducting the validation of cleaning processes, processing and packaging
equipment, and utility services. His validation project management activities have included the validation of a complex, FDA-compliant
computerized document management system. As
a pharmaceutical-manufacturing engineer, with a comprehensive background in turnkey pharmaceutical engineering projects, he
has provided technical expertise for both single machine implementation and complex-line system integration. He has focused
on the selection, justification, installation, validation and implementation of packaging and processing equipment. He has
provided systems for the containment and control of highpotency pharmaceutical formulations and specified and implemented
Clean-in-Place systems. Mr. Chalmers has also provided technical expertise in the design of equipment, cleaning processes,
and SOP's to facilitate cleaning validation. - As
a project manager, he has extensive experience in all phases of manufacturing automation needs, equipment space planning,
design ergonomics, facility and utility construction requirements, equipment and facility clean-ability, and the overall equipment
investment requirements for pharmaceutical manufacturing projects. Mr. Chalmers has provided skilled leadership to address
the key issues of personnel training, deployment and interaction with equipment as part of machine/line integration. Mr. Chalmers
is a skilled user of computer aided design (CAD) and project management software packages.
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