Steyer Consulting Engineering Resources provides a broad range of Engineering Services: from Aseptic Process Development and Process Optimization through Statistical Quality Control, Design Of Experiments, & Measurement System Analysis, to Project Engineering: Designing Large Capital Project including Aseptic cGMP Facilities, Aseptic cGMP Processes, cGMP Laboratories, to cGMP Warehouse, through Commissioning Facilities, Equipment, & Processes, and Validation of: Aseptic Processes, Aseptic Equipment, Aseptic Facilities, Cleaning, Sterilization, and Depyrogenation.
Steyer Consulting also specializes in: Failure Mode and Effects Analysis, Hazard Analysis and Critical Control Point Analysis, Statistical Quality Control Analysis, Measurement System Analysis (Gauge R&R), Analytical Analysis, and Design of Experiments; Solid working knowledge of: DMAIC/DFSS, Lean techniques and methodologies.
Steyer Consulting is Accomplished at writing: Standard Operating Procedures (SOP), Manufacturing Operation Procedures (MOPs), Work Instructions, Sequence of Operations (SOO), User Requirement Specification (URS), Batch Production Documents (BPD), Equipment Specifications, Calibration Limits, and Procedures for pharmaceutical and/or medical device processes and facilities.
Steyer Consulting Engineering Resources is Experienced and intimately familiar with: Title 21 CFR Parts 11, 58, 210, 211, 820, & 1301.72. ASTM E2500, EU Directive 2003/94/EC, EudraLex - Volume 4, HTM2010, MHRA 2007, ICH Guidelines Q7, through Q11, and ISO 13485 & 14971, Japanese MHLW Ministerial Ordinances, ANSI/NCSL Z540, and NCSL RP1, RP12, & RP18.
“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."