About Augmented
Manufacturing experience applied to qualification strategy
Augmented Engineering Solutions is a principal-led CQV and validation consultancy serving biopharmaceutical, cell therapy, and regulated manufacturing organizations.
Company overview
Engineering evidence connected to manufacturing use
The company’s approach connects engineering documentation, manufacturing requirements, risk management, field execution, and qualification evidence into a practical lifecycle focused on operational readiness.
Work can be structured as focused technical advice, a defined CQV work package, or integrated project leadership based on the project’s actual needs.
Principal
Robert Rodriguez
President and Principal Consultant
Professional progression from manufacturing operations to manufacturing SME, C&Q project leadership, operations supervision, and independent consulting.
Manufacturing and qualification experience
- Hands-on cell culture experience from vial thaw through harvest
- CIP and SIP execution experience
- Bioreactor experience from approximately 100 L to 15,000 L
- Experience with centrifuges
- Experience with chromatography skids
- Experience with UF/DF systems
- Experience with WFI systems
- Experience with HVAC
- Experience with cell therapy cleanroom environments
- Experience supporting and leading CQV activities
- Experience representing manufacturing as an SME during FDA inspections or audits
- Experience with Validation Master Plans
- Experience with FAT, SAT, IQ, OQ, and PQ
- Experience with requirements traceability
- Experience with turnover and closeout
- Experience with CSV and GxP computerized systems
Operating philosophy
Qualification should reflect how the system will actually be used
Augmented approaches CQV as an operating-lifecycle discipline. Requirements, design decisions, risks, vendor testing, field evidence, procedures, maintenance needs, and manufacturing use must remain connected throughout the project.
Engagement principles
How the work is approached
Practical technical judgment
Risk-based execution
Clear documentation
Direct senior involvement
Based in Los Angeles, California
Supporting on-site, remote, and hybrid engagements based on project needs.