About Steyer ConsultingEngineering

Steyer Consulting Engineering Resources has over thirty years of experience as a proficient Senior Principal Aseptic Process Development Engineer, Biochemical Process Development Engineer, Gene Therapy Engineer, Cell Therapy Engineer with Pre-Approval Inspection Readiness, Remediation Engineering, and Validation Engineer on: Large Capital Projects, Aseptic Process Development, Process Development, Radioligand Theragnostic Development, In Vitro Diagnostics Processes, Process Equipment: both Conventional and Single-use-Systems, Scale-up, Technology Transfer, Contamination Control Strategies, Validation, Sterilization Development: EtO, gamma, e-Beam, VHP, & Steam Sterilization, Cleaning Validation, and Training for the pharmaceutical and medical device industries.  Our team specializes in optimizing these processes to ensure effective compliance and reduced risk of contamination.

Steyer Consulting Engineering Resources provides design, revision, and vendor relations for all types of aseptic facilities, conventional facilities processes, products, systems, and equipment: Processes: API & biochemical process plants, plant additions & modifications to new construction, aseptic sterile injectable products, aseptic dry-products (lyophilization), and spray drying APIs. Facilities: fluid flow systems, pump and pipe sizing, SIP & CIP development, water systems (RO & WFI), heat exchanger configurations, and sizing. Systems and Equipment: single-use aseptic fill/finish, conventional fill/finish systems, bioreactors and fermenters, protein purification to combination medical devices.

Steyer Consulting Engineering Resources is quintessential in Statistical Analysis: Univariant Statistics, Statistical Quality Control, Statistical Process Control, Multivariant Statistics, Multivariant Process Control, Measurement System Analysis (GR&R) to Design of Experiments: factorial designs & fractional factorial designs, and Computer Aided Design (CAD) with: R Statistical Language, AFT Fathom, JMP Pro, & AutoCAD. Solid working knowledge of: DMAIC/DFSS, lean techniques and methodologies.

Additionally, Steyer Consulting Engineering Resources is accomplished at writing & executing: EBOD, EPP, FRS, HDS, SDS, URS, FAT, SAT, IQ, OQ, PQ, PV, PPQ, and EMPQ protocols and reports, master validation plans, data-based risk assessments, Contamination Control Strategies, Leachable/Extractable, Root Cause Analysis, Standard Operating Procedures, Manufacturing Operation Procedures.