MES (PAS-X) Lead Engineer

MES (PAS-X) Lead Engineer (Biotech/Pharmaceutical)

Location – Wilson, NC

Aztec Technologies is an engineering and consulting firm providing expertise in the

pharmaceutical and biotechnology industries. Aztec Technologies and Aztec Process Automation

are part of Trinity Consultants Company.

Trinity Consultants, Inc., a leading international EHS, life sciences and environment consulting

services with 1500 engineers worldwide.

Aztec Technologies provides solutions for Manufacturing Applications:

• Process and Facility Automation

• Project Management

• MES

• Data Analytics

With offices across 3 continents, consulting firm with over 20 years of experience within the

biopharmaceutical and pharmaceuticals industries.

The successful candidate will work with a group of engineers involved in the design, automation,

commissioning and start-up of various processes, systems, and facilities. A combination of

strong technical aptitude, automation engineering skills and technical writing are the desired skill

set. This is an outstanding opportunity to join our growing team and to work in the Life Sciences

space that will enhance professional opportunities!

Candidates need to be local or willing to relocate to the areas of operation where we have open

opportunities for immediate hire in the Wilson, NC area:

Key Responsibilities:

• Own MES configuration management for PAS-X, including:
• Manufacturing Batch Records (MBRs)
• Material management
• Equipment and timer management
• Label management
• Lead MES design, configuration, testing, and troubleshooting
• Act as technical interface between MES, DCS (DeltaV), ERP, LIMS, and other shop-floor systems
• Support MBR migration from a legacy site
• Ensure alignment with site and global MES standards
• Support risk assessments and GMP compliance activities
• Provide hands-on troubleshooting and technical support during execution
• Develop and maintain MES technical documentation
• Collaborate closely with IT, Manufacturing, Quality, and Engineering teams

Required Qualifications

• 8 years experience in pharmaceutical or biopharmaceutical manufacturing environments
• Strong hands-on experience with MES platforms, preferably Werum PAS-X
• Proven experience with MBR design and execution
• Solid understanding of GMP manufacturing processes
• Experience integrating MES with DCS (DeltaV) and enterprise systems
• Strong analytical, troubleshooting, and problem-solving skills
• Bachelor’s degree in Engineering, IT, Science, or related discipline

Preferred / Nice-to-Have Skills

• Programming experience: .NET, SQL / PL-SQL, Java
• Experience with OPC servers/clients
• Knowledge of 21 CFR Part 11 and EU GMP Annex 11
• Process knowledge across:
• Upstream
• Downstream
• Bioprocess support functions
• Ability to communicate effectively with both technical and non-technical stakeholders

Ideal Candidate Profile:

• Senior-level PAS-X MES SME
• Strong on-site presence and ownership mindset
• Comfortable operating as Owner’s Rep, not a junior configurator
• Deep pharma/biotech automation background
• Able to bridge Manufacturing, IT, Automation, and Quality