Client Testimonials for Aseptic Process, Facility & Validation Engineering
Steyer Consulting Engineering Resources LLC has earned the trust of pharmaceutical, biotechnology, & medical-device organizations through the consistent delivery of technically defensible, Senior Principal-level results across aseptic-process, contamination-control, & facility-engineering engagements from concept through operational readiness.
The testimonials below reflect direct client experience working with Steyer Consulting Engineering Resources LLC on aseptic process improvement, equipment validation, & facility construction initiatives. See Services for a complete list of engineering consulting offerings.
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“I hired Kirk at Sublime Stericeuticals for consulting work toward thermodynamic and mass transfer proof-of-concept calculations for a freeze-drying application. He did excellent work, had his work checked for accuracy and applicability by a second engineer, and provided an exceptional report that was easy for me to understand as a non-engineer. This report has proven to be key in early fundraising efforts for development and testing of our continuous lyophilization system.
Prior to his consulting appointment at Sublime, Kirk and I worked side-by-side on several aseptic process improvement projects at Pfizer. Kirk is an A-to-Z specialist in Aseptic Process Engineering and always came through with innovative, practical approaches to the challenge at hand. The presentation of his end-product solutions was always well thought out. I also appreciated his candor and forward-looking, pragmatic solutions. Kirk handles his assignments straight on, distills them down, and presents several solutions while minimizing risks to implementation timelines, operational impact, product quality, and budget. I highly recommend Kirk for any and all project or process engineering work. I know I will be working with him again in Sublime’s future initiatives.”
Joel Meyer
Co-Founder/President/CEO
Sublime Stericeuticals Corporation
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"Kirk worked as a consultant for Alexza Pharmaceuticals commissioning and validating process equipment. Kirk was 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."
Ken Dick
Pharmaceutical / Medical Device Engineer
Alexza Pharmaceuticals
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"I met Kirk when he was 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 Kirk's 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 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.”
Thomas Dolim
Pharmaceutical Engineer
Former Colleague
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“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.”
Richard Lee
Process Development Engineer
Former Colleague
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