Steyer Consulting Engineering Resources provides a broad range of Engineering Services from: Aseptic Process Development, Project Engineering, and Validation Engineering on: Large Capital Projects, Aseptic Process Development, Process Development, Clinical Trial Process Development, and Equipment Design: both Conventional and Single-use-Systems.
Steyer Consulting Engineering Resources provides services for: Scale-up, Technology Transfer, Validation, EO, gamma, e-Beam, VHP, & Steam Sterilization development, and Training for the pharmaceutical and medical device industries.
Steyer Consulting Engineering Resources previous projects involved: Designing new novel aseptic single-use systems, aseptic facilities, and aseptic equipment to writing and executing all types of engineering documents BOD, EPP, URS, FAT, SAT, IOPQs and protocols to data-based risk assessments, pFMEA, sFMEA, HACCP, to Capital Appropriation Requests and Engineering Change Orders.
Steyer Consulting also specializes in: statistical quality control analysis, measurement system analysis (Gauge R&R), analytical analysis, design of experiments: Resolution III Fractional Factorial Designed Screening Experiments and Design of Experiments, Computer modeling, Monte Carlo Simulations, and Computer Aided Design (CAD) with: R Statistical Language, SupperPro Designer, Simsci’s ProII, AFT Fathom, JMP Pro, & AutoCAD.
Steyer Consulting Engineering Resources is Experienced and intimately familiar with all aspects of regulation involving: FDA, EMA, HMRA, Heath Canada, TGA (Australia), COFEPRIS (Mexico), AIFA (Italian), HPRA (Irish), CFDA China), and PMDA (Japan), ISO, ICH, PDA, ANSI, AAMI, USP, Regulatory Standards.
“I met Kirk when he working as a consultant at Impax Laboratories in a role as Project Engineer. Kirk was managing an $11M design build project to gut, renovate, commission and qualify the facilities and equipment for a 70,000 sq. ft. temperature and humidity controlled cGMP warehouse, complete with a raw materials QC Sampling Laboratories and DEA Certified Schedule II Controlled Substance Vault. This project had many stakeholders, with differing needs and wants, which on a project of this size resulted in a great number of issues and challenges. Kirk dealt with the issues head on with decisive options for the stakeholders and efficient execution of the decisions made. The combination of Kirks experience, engineering knowledge and commitment to getting a project done right, on time and at the best value for his customers is inspiring and unique in my 25 years working in this industry. I would highly recommend Kirk for any project engineering or equipment validation work.Kirk worked as a consultant for Impax Laboratories as a Project Engineer: designing, building, and commissioning the facilities and equipment for a 70,000 sq. ft. temperature and humidity controlled cGMP warehouse, with QC Sampling Laboratories and Schedule II Controlled Substance Vault. Kirk is unprecedented at dealing with details and issues which, as usual, occurred during any large construction project. To speak favorably of Kirk for any project engineering, facilities engineering, or equipment validation, for Kirk's knowledge and commitment to engineering was extraordinary.”
“Kirk worked as a consultant for Matrix Laboratories as a Process Engineer: designing and validating the equipment for the aseptic processing of an injectable collagen based API. Kirk’s ability to assess an issue and design a solution is without equal, dealing with the myriad of details and issues which arise in an aseptic environment. I would endorse Kirk for any aseptic engineering or equipment validation work. Kirk's knowledge and commitment to engineering was singular and above reproach.”
Kirk worked as a consultant for Alexza Pharmaceuticals commissioning and validating process equipment. Kirk is very detailed oriented and does a very good job of defining project objectives and goals. I would highly recommend Kirk for any equipment validation work. Kirk's attitude and enthusiasm was exceptional."