Cliff Hardie

Cliff Hardie Email and Phone Number

Equipment Engineering Manager, Equipment Engineer, Validation Engineer, Process Excellence Master Black Belt certified by J&J, Project Manager, Heath & Safety. Manufacturing Equipment Expert. @
Cliff Hardie's Location
Nairn, Scotland, United Kingdom, United Kingdom
Cliff Hardie's Contact Details

Cliff Hardie personal email

About Cliff Hardie

Highly motivated Equipment Engineering Manager, with a strong background in medical devices (Diabetes & Ophthalmic Healthcare), project management, product design, mechanical engineering. Over 30 years in various engineering roles covering a wide array of High Risk/Investment Engineering projects, delivering continuous improvement, automation, process scale-up and product transfer, quality and validation. An established leader who has worked within a global environment for the medical industry over the last 17 years. KEY SKILLS:- Mentoring members of staff in career development. - Supporting the business in teaching Process Excellence methodologies/applications.- J&J Certified Master Black Belt- Analytical & creative problem solving- New product & process development- J&J Trained in Flawless Project Execution (FPx) & PMP - Strong communication written & verbal- Ability to build strong relationships across Johnson & Johnson at a multi-cultural, global levelQUALIFICATIONS & TOOLS:- Member of the Institute of Engineering & Technology (MIET)- Certified Master Black Belt in Process Excellence (PEx).- Project Management- Quality Systems- GAMP- Equipment and Process Validation- Minitab- Microsoft Office tools- FMEA- AutoCAD & SolidWorks- Statistical Process Control (SPC)- Strong Knowledge in FDA Requirements- Product Design & Change ControlEXPERIENCE SUMMARY:- Development of the LumiraDX POC product line. Multiple Assays including COVID SARS 19 test products.- Equipment Engineering Manager with direct reports of 10 equipment engineers and 24 maintenance engineers.- Program Manager for 2 Healon product manufacturing lines in Sweden 2017 – 2018- Project Manager for New insulin pump, med/high volume manufacturing line (Global Project - 31,000 Sqr. Ft.) 2016 – 2017- Project Manager for New insulin pump, Low Volume Semi-automated Manufacturing Line. 2012 – 2016 - Lead Engineer for the Engineered Top-Tape Lamination Machine. 2009 – 2012- Responsible as lead engineer for multiple Operations Automation Projects.- Responsible to support New Product Design projects providing Engineering Support by Contributing DFM activities.Full CV Available upon request.

Cliff Hardie's Current Company Details
AGR Automation (Convergix Automation Solutions - UK)

Agr Automation (Convergix Automation Solutions - Uk)

Equipment Engineering Manager, Equipment Engineer, Validation Engineer, Process Excellence Master Black Belt certified by J&J, Project Manager, Heath & Safety. Manufacturing Equipment Expert.
Cliff Hardie Work Experience Details
  • Agr Automation (Convergix Automation Solutions - Uk)
    Project Manager
    Agr Automation (Convergix Automation Solutions - Uk) Oct 2024 - Present
    Arbroath, Scotland, United Kingdom
    I am delighted to be working on the other side of the table as it is very interesting. Use to be working for the customer who wants equipment built, now working on the supplier side of delivering equipment to the customers :-)
  • Integrated Graphene
    Equipment Engineering Manager
    Integrated Graphene Sep 2022 - May 2024
    Stirling, Scotland, United Kingdom
  • Lumeriadx, Stirling, Uk
    Equipment Engineering Manager
    Lumeriadx, Stirling, Uk Aug 2019 - Sep 2022
    Stirling, Scotland
  • Lifescan Scotland
    Principal Engineer
    Lifescan Scotland Jan 2015 - Sep 2018
    Inverness, Scotland
    Overall responsibility as lead project manager for multiple high-investment automation projects. Responsible for delivering new product development, equipment design, project management & validation. An established leader who has worked within a global environment for the medical industry over many years. Accomplished professional delivering many high-cost projects within a high-volume regulated industry.
  • Lifescan Scotland
    Staff Engineer
    Lifescan Scotland Apr 2012 - Dec 2014
    Inverness, United Kingdom
    PM Lead for New Calibra insulin pump product, Low Volume Semi-automated Manufacturing Line.• Responsible to support J&J in the develop a strong business case for this new product.• Responsible for evaluating R&D documentation and use this to generate a well-defined user requirement specification (URS) to be used in the development of an automated assembly line solution.• Responsible for all budgeted finance (spend and monitoring), scheduling, planning, and upper management reporting throughout the project.• Leading training activities to all members of staff (operators to senior engineers) on all aspects of Calibra patch pump Other Projects Delivered: ‘ETT’ Manufacturing Inspection Vision System Project. Feb 2012 – Apr 2013o Vision System 1: J&J team to assist in the optimization and evaluation of Polarseal’s current inspection system.o Vision System 2: Development and integration of a new vision system based on the knowledge gained through Vision System 1.
  • Lifescan Scotland
    Senior Project Engineer
    Lifescan Scotland Dec 2006 - Apr 2012
    Inverness, United Kingdom
    Overall responsibility as lead engineer for multiple Med/High-investment automation projects. Lead Engineer for the Engineered Top-Tape (ETT) Lamination Machine Project.  Responsible for the preparation of capital investment request, Equipment scheduling, and giving regular update reports to the PM throughout the project. Successfully delivered, what was classified by management as a world class machine, in quality, design and performance. The ETT Laminator continues to achieve 6 sigma or higher in its performance evaluations to date.Other Projects Delivered: Successful delivery of Web 1 Punch Flexibility Project for the OneTouch Product range. o Responsible for the design and delivery of a Read, Print & Verify 2D DM Code system that will be fitted to the existing Web Punch 1 machine.  Successful delivery of Carbon Row Length Measurement System (CRLM) for Web 2 o Responsible for the design and delivery of an integrated vision system on Web 2 that measured the location of the carbon print and allowed manual adjustment of the web without stopping the process.
  • Lifescan Scotland
    Engineer Ii
    Lifescan Scotland Jan 2004 - Dec 2006
    Inverness, United Kingdom
    Overall responsibility as lead engineer for Operations Automation Projects. Successful delivery of 7 Automatic Vial Integrity Test Machines for the OneTouch Product. o The PDT machines were used to test for leaks in the primary packaging (vials), which protects the test strips from moisture ingress.
  • Lifescan Scotland
    Engineer I
    Lifescan Scotland Nov 2002 - Jan 2004
    Inverness, United Kingdom
    Responsible to support New Product Design projects also providing Engineering Support by Contributing DFM activities to aid the Automation Development. Successful delivery of New Heat Seal Lamination Machine for the ULTRA ‘C’ Project. o The ULTRA ‘C’ product required a Heat-Sealing process for Lamination and therefore a new lamination machine had to be developed as LifeScan’s current manufacturing process used pressure lamination.
  • Lifescan Scotland
    Graduate Engineer
    Lifescan Scotland Nov 2001 - Nov 2002
    Inverness, United Kingdom
    Responsible to support New Product Design for R&D Projects. Successful delivery of the design optimisation on the ULTRA ‘C’ Dispenser used in the New Test Strip Meter o When I joined LifeScan the ULTRA ‘C’ Product already had an early but not yet optimised Dispenser Design for the Meter. I was asked to work on this Component improving functionality and added DFM methodologies. I succeeded in delivering a fully optimised dispenser, which functioned well under all testing evaluations.

Cliff Hardie Skills

Fda Capa Validation Design Of Experiments Fmea Quality System Dmaic Six Sigma Gmp R&d Root Cause Analysis Spc Gamp Lean Manufacturing Computer System Validation Quality Management Change Control Failure Mode And Effects Analysis U.s. Food And Drug Administration

Cliff Hardie Education Details

Frequently Asked Questions about Cliff Hardie

What company does Cliff Hardie work for?

Cliff Hardie works for Agr Automation (Convergix Automation Solutions - Uk)

What is Cliff Hardie's role at the current company?

Cliff Hardie's current role is Equipment Engineering Manager, Equipment Engineer, Validation Engineer, Process Excellence Master Black Belt certified by J&J, Project Manager, Heath & Safety. Manufacturing Equipment Expert..

What is Cliff Hardie's email address?

Cliff Hardie's email address is ch****@****jnj.com

What schools did Cliff Hardie attend?

Cliff Hardie attended Heriot-Watt University.

What skills is Cliff Hardie known for?

Cliff Hardie has skills like Fda, Capa, Validation, Design Of Experiments, Fmea, Quality System, Dmaic, Six Sigma, Gmp, R&d, Root Cause Analysis, Spc.

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