Steyer Consulting Engineering Resources LLC

A Consummate Senior Principal Biochemical Engineering Consultant & Aseptic Process Development Engineer

Serving Pharmaceutical, Biotechnology, & Medical-Device Organizations.

Provides Senior Principal-level engineering consulting for complex aseptic manufacturing, facility, equipment, validation, & remediation programs: guiding gap assessments, technical reviews, risk-based strategies, & cross-functional execution from concept development through qualification, inspection readiness, & operational handover.

Delivers Senior Principal-level expertise across Aseptic Process Development, Biochemical Process Development, Process Optimization, Process Design Verification, Architecture, Engineering & Construction (A/E/C) Oversight, Contamination Control Strategies, QRM-based Risk Assessment, Technology Transfer, Pre-Approval Inspection Readiness, Sterilization Development, & cGMP Remediation, supporting regulatory-ready implementation. See Services for more.

Applies Statistical Quality Control, Measurement System Analysis (Gauge R&R), analytical data evaluation, Design of Experiments, fractional-factorial screening designs, process modeling, & Monte Carlo simulation, using R Statistical Language, JMP Pro, SuperPro Designer, AFT Fathom, & AutoCAD to quantify capability, improve measurement controls, optimize operating parameters, & evaluate engineering alternatives. See Services for more.

Translates FDA, EMA, MHRA, Health Canada, TGA, COFEPRIS, AIFA, HPRA, NMPA, & PMDA expectations, together with applicable ISO, ICH, PDA, ANSI, AAMI, & USP standards & guidance, into practical technical, quality, & remediation decisions.

Available for corp-to-corp engagements; contact to discuss scope.