Services
An Aztec Engineer:
Aztec employs automation engineers (degreed chemical, electrical, instrumentation, and mechanical engineers) with various levels of experience ranging from 2 - 25+ years. Our engineers have experience in the BioPharmaceutical, Petrochemical and Refining industries. Each project is assigned a senior engineer with industry expertise aligned to the project at hand. Our senior engineers have managed and led teams in Engineering, Information Technology and Computer Validation in all of our core industries.
We hire engineers who have been involved with the design, construction, commissioning, startup and validation of large new active ingredient manufacturing facilities. As a result Aztec has successfully executed projects in commissioning and startup of bioreactors, chromatography skids, WFI and Clean Steam systems, CIP skids along with other process/utility equipment.
Our BioPharmaceutical practice is truly unique in its IT capacity. Our team has expertise deploying systems across an enterprise including ERP, LIMS, DCS, MES, EDMS, CMMS and LMS. Our practice lead has developed best practices and performed business process re-engineering to meet client requirements without requiring extensive customization of applications. Aztec takes pride in its execution of and create of policies and procedures for IT, Engineering and Computer Validation departments.
Our team has participated in many successful regulatory inspections and has been responsible for working with and leading various teams to prepare facilities and computer systems for successful US, European and Canadian regulatory inspections.


Aztec’s Services for the BioPharmaceutical Industry:
Process Automation
Aztec is comprised of engineers with deep experience in process automation, specifically for batch manufacture. Our engineers have designed, implemented, commissioned and started-up plants ranging from 100 to 20,000 Input/Output points. We utilize project lifecycle methodologies such as GAMP, S-88, and PMA Lifecycle. Aztec engineers utilize a standardized development practice, meaning the software produced by one Aztec Engineer is the same as anothers’. Furthermore, Aztec staff is composed of degreed Chemical, Electrical and Mechanical engineers with over 100 years of process automation and instrumentation experience. We believe that engineers staffing projects should understand the process, rather than just understanding the code. Our engineers are experts in Distributed Control Systems, SCADA, PLC’s, Project Execution from design to ongoing support, instrumentation, and data archiving and reporting.
Project Management
Aztec senior consultants are trusted project architects. Our project managers have experience executing major capital projects at 4 of the largest Pharmaceutical companies in the world and major Water/Wastewater facilities and have experience managing projects over $100 million in scope. Furthermore, our senior consultants have managed globally dispersed assets, overseeing global expansions at major Life Sciences companies. Our core competencies are: Process Automation, Information Management, Enterprise Systems, Mechanics and Instrumentation, and Validation and Quality Assurance.
Information Technology
Aztec has experience selecting, implementing, validating and supporting a variety of enterprise systems. We have experience implementing systems at multiple sites across enterprises in various countries. Our experience with systems includes the following: ERP, DMS, LIMS, LMS, CAPA, and CMMS. We also offer application and database development solutions to our clients and can provide custom database development in addition to application development services.
Regulatory Services
Our staff can provide pharmaceutical firms with a range of services designed to improve compliance and enhance “inspectability.” Our personnel have experience with preparing facilities and systems for FDA, EMEA, HCA and other regulatory bodies. We provide practical solutions to compliance based on experience as a result of which our approach has been validated by 5 successful regulatory inspections. We provide services in: internal and vendor audits, quality documentation program development, commissioning, and training. Our staff is also highly capable of validating computer control systems and enterprise-wide systems. We can supplement your internal computer validation resources with our personnel who have extensive experience with ever changing regulations. We combine experience and expertise with a risk based approach to computer validation. Finally, we also offer 21 CFR Part 11 remediation and IT architecture qualification for validated processes.