Steve Mikolajewski

Steve Mikolajewski Email and Phone Number

IT and OT Lead @ cGMPnow
Westminster, CO, US
Steve Mikolajewski's Location
Westminster, Colorado, United States, United States
Steve Mikolajewski's Contact Details
About Steve Mikolajewski

Experienced Process Automation professional with over 20 years experience in project execution and management from conceptual design through commissioning. Providing technical leadership for control system architecture and design, automation master plans, application engineering, configuration, commissioning & startup. I have worked in highly regulated, cGMP manufacturing facilities ensuring development and approval of functional and detail design documents, SOPs, software development and automation testing.Specialties: DeltaV, Rosemount System 3 (RS/3), PI Data Historian, OPC, data integration with Rockwell, Siemens, Honeywell, Opto22, control system lifecycle management, network architecture, data integrity and regulatory documentation

Steve Mikolajewski's Current Company Details
cGMPnow

Cgmpnow

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IT and OT Lead
Westminster, CO, US
Website:
cgmpnow.com
Employees:
28
Steve Mikolajewski Work Experience Details
  • Cgmpnow
    It And Ot Lead
    Cgmpnow
    Westminster, Co, Us
    View
  • Cgmpnow
    It/Ot Lead
    Cgmpnow Jun 2020 - Present
    Boulder, Colorado, Us
    Providing IT/OT leadership, project management and network architecture design to Cell and Gene Therapy clients while bringing over 28 years experience in the FDA regulated Life Sciences industry.
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  • Vista Engineering Group
    Principal Engineer
    Vista Engineering Group Sep 2016 - Present
    Broomfield, Co, Us
    Providing technical leadership and owner's rep automation engineering services for clients. Current and past projects include:- Automation master plan and system architecture development- Data integrity technical leadership- Project management for facility expansion- DeltaV hardware and software support- PI system implementation- Lifecycle projects- Generation of design (URS, FS, DS), commissioning (IOQ) and SOP documentsClients include Ampio Pharmaceuticals, AveXis, Corden Pharma, and Molson Coors.
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  • Amgen
    Principal Operations Information Systems (Ois) Automation Engineer
    Amgen May 2012 - Sep 2016
    Thousand Oaks, Ca, Us
    Corporate automation project manager responsible for automation project delivery working both as a lead and as part of a project team. Delivered projects of varying scale up to $3.0M in automation scope. Includes technology transfer from one site to another, new product introductions, multiple biotech process equipment skids, lifecycle management projects for DeltaV, PI and Rockwell.
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  • Ch2M Hill
    Project Engineer
    Ch2M Hill Nov 2011 - May 2012
    Englewood, Colorado, Us
    Client representative providing technical leadership for large capital site expansion project.
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  • Roche Pharmaceuticals
    Principal Process Automation Engineer
    Roche Pharmaceuticals Apr 1997 - Oct 2011
    Switzerland 🇨🇭 , Ch
    Lead process automation engineer for facility manufacturing bulk active pharmaceutical ingredients for peptides and small molecules. This includes installation, configuration, administration and integration of systems including DeltaV, RS/3, Rockwell Allen-Bradley, Siemens, Honeywell EBI, Opto22 and OSIsoft’s PI. Generation and execution of regulatory documentation including URS, FS, SDS, HDS, IOQ and SOPs.
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  • Abbott Laboratories
    Process Engineer
    Abbott Laboratories May 1993 - Apr 1997
    Abbott Park, Illinois, Us
    Provided manufacturing technical support for processes, equipment and control systems.
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Steve Mikolajewski Skills

Computer System Validation Automation Control Systems Design Manufacturing Change Control Emerson Deltav Validation Gmp Process Engineering Integration Process Automation Process Simulation Fda Allen Bradley Engineering Pharmaceutical Industry Osisoft Pi Biotechnology Chemical Engineering Commissioning Webdav Troubleshooting Sop 21 Cfr Part 11 Dcs Gamp Plc Process Control Quality Assurance U.s. Food And Drug Administration Quality System Technology Transfer

Steve Mikolajewski Education Details

  • Michigan State University
    Michigan State University
    Chemical Engineering

Frequently Asked Questions about Steve Mikolajewski

What company does Steve Mikolajewski work for?

Steve Mikolajewski works for Cgmpnow

What is Steve Mikolajewski's role at the current company?

Steve Mikolajewski's current role is IT and OT Lead.

What is Steve Mikolajewski's email address?

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What is Steve Mikolajewski's direct phone number?

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What schools did Steve Mikolajewski attend?

Steve Mikolajewski attended Michigan State University.

What skills is Steve Mikolajewski known for?

Steve Mikolajewski has skills like Computer System Validation, Automation, Control Systems Design, Manufacturing, Change Control, Emerson Deltav, Validation, Gmp, Process Engineering, Integration, Process Automation, Process Simulation.

Who are Steve Mikolajewski's colleagues?

Steve Mikolajewski's colleagues are Grayson Heller, Alexis Hoecher, Cathryn Toomey, Daniel Swanson, Pe Pmp, Dave Elmore, Daniel Hanley, Christopher Herskovits.

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