Have you plateaued at work? Has your job become routine and monotonous? Has your salary growth flatlined? Fed up working outside on cold construction sites? You’re not alone but this program could help you restart your career.
Minimum Entry Requirements
This program is highly specialized so you MUST have one of the following:
- You are a plumber/pipefitter/pipe welder (e.g. high purity pipe fitter and orbital welder) / site-foreman / instrument or boiler technicians (i.e. you can interpret technical drawings, especially P&IDs and pipe skids).
Or - You have 1 year or more of GMP manufacturing experience or have a recognized GMP certificate or qualification.
Or - You have commissioning & qualification experience in ANY INDUSTRY e.g. Oil and Gas, Food Manufacturing, Mechanical Construction, etc.
Or - You work in Quality Assurance or Quality Control in the pharma/medtech industry and are worried about having to sign off on validation documents you don’t fully understand!
Or - You are a chemical / process / petroleum / project / mechanical engineer or a lab/scientist and want to move into a validation role or you improve your background knowledge on validation for the majority of it was not covered in your degree.
Or - You already work in validation (e.g. mechanical contracting company carrying out high-purity pipework installations) but have no formal training on IQ OQ PQ validation protocols and want to learn more.
What Validation Roles Could I Retrain For?
STEP 1, you take this “Starter Validation Course” to retrain for the following roles;
- Validation Technician – you work directly for a pharmaceutical company on ongoing projects.
- Validation Team Member – you work with an engineering consultancy firm on capital projects.
(Note that actual job titles may vary – the distinction is more between who’d employ you and what type of projects you’d work on).
STEP 2, then take our Certificate in Validation program for Senior Validation Roles to get a level 7 university qualification from Technological University Dublin, Ireland and a more interesting job with a higher salary such as;
Some companies might call this role: CQV Engineer, Validation Specialist or C&Q Specialist
STEP 3, take our Computer System Validation Course and extend your role to CSV Projects. Round out your qualifications and give yourself a competitive edge in the marketplace.
Enroll in this program to learn…
- How to prioritise which parts of the equipment system are critical to validate and which parts are not etc, using component impact assessments and risk management tools.
- How to read/interpret the engineering documentation such as P&IDs, Piping Isometrics & Electrical Loop Drawings used to define the equipment system.
- How the intent of a process (like maintaining the product at the required temperature) is linked to the equipment that will be used to do this.
- The tests along with the functional test scripts necessary to confirm that the installed equipment is fit-for-purpose, i.e. that it will do what it states that it will do based on the User Requirement Specifications).
- How to use a traceability matrix tool to ensure that all requirements defined within the User Requirement Specifications (URS) are tested in the protocol.
- How to qualify equipment, instruments and piping systems, and automation controls.
- How to document all of these steps in validation protocol which you will develop as your end of module assignment.
You’ll produce your own 100-page plus IQ OQ PQ Validation Protocol to commission and qualify a clean-in-place system
The protocol will detail the following elements;
- Product characteristics – showing what your system is looking to achieve/produce
- Production equipment – detailing the equipment necessary
- Test scripts and methods – telling you the steps involved in conducting a test
- Test parameters and acceptance criteria – defining acceptable test results
- Test checksheets – documenting and recording the test results
- Final approval – documenting that the validation process has been successfully carried out
There are 2 modules in this 15-week program
Module 1 – Manufacturing Safe Medicines and Medical Devices (GMP) (Weeks 1-5)
In this module, you’ll learn about the systems used in pharmaceutical manufacturing. You’ll learn about the rules and regulations such as Good Manufacturing Practices (GMPs) that you need to follow. And you’ll learn enough technical information to get you talking to employers.
Module 2 – Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems (Weeks 6-15)
This is the validation bit. In this module, you will develop your own 100-page Validation Protocol to commission and qualify a clean-in-place system. You will also learn to read P&IDs, Piping Isometrics & Electrical Loop Drawings used to Develop Validation protocols. And you’ll learn how to qualify equipment, instruments and piping systems, along with automation controls and building facilities.
Already Have Validation Experience?
If you already have some experience working in Validation and know how to populate an IQ OQ PQ validation protocol, check out our academically accredited Pharmaceutical Validation Training Course (Online) – For Senior Validation Roles.
So What Is Validation?
Validation creates a documented evidence trail (through rigorously checking and testing) to demonstrate that a system, procedure or process used in the production and testing of the pharmaceutical product:
- maintains compliance at all stages
- and leads to a consistent and reproducible result
There are many other definitions of validation but the essence of all these definitions seems to be “documented scientific proof of consistent performance“.
Commission and Qualification is one part of a larger validation process for making sure that a facility – and the equipment in it – will function as required and be approved by the regulatory agencies that have jurisdiction over that facility.
An IQ OQ PQ Validation Protocol is a written plan stating how validation will be conducted including test parameters, product characteristics, production equipment and decision points on what constitutes an acceptable result.
IQ OQ PQ or Installation Qualification, Operational Qualification and Performance Qualification are 3 independent and documented procedures used together (when executing a validation protocol) to check and test that a mechanical or software system is;
- installed correctly
- meets its design requirements and specifications
- operates the way in which it was designed under load
Need More Detailed Information?
What are IQ, OQ and PQ?
What is a Validation Protocol?
IQ, OQ PQ Templates
Watch this Video on a Validation Engineer’s Role!
For a great insight into validation roles from someone actually in the job, check out this video from the About Bioscience website, produced by the North Carolina Association for Biomedical Research (NCABR).
Hear From People Who’ve Taken This Course
Regina McNamara
Previous background:
Professional Painter
“I Can Study Around Work and Family Commitments”
Studying online is working well for me as I study around work and family commitments.
I would recommend this course to anyone that wants a new career in the Pharmaceutical and Medical Device Manufacturing industry.
Mehmet Hascan
Previous background:
Technical Support
“Material was Delivered in an Engaging, Interesting and Supportive Way”
The administration staff and lecturers at Getreskilled are first class and the course material was delivered in an engaging, interesting and supportive way.
I have now been working at Johnson and Johnson Vision Care as Validation Engineer in Limerick and I look forward to put what I have learned into practice.
Sharon Egan
Previous background:
Food Manufacturing
“Structurally Well Planned with the Opportunity for Practical Application”
I found it to be interesting, structurally well planned with the opportunity for practical application of the course modules through various assignments.
I have worked in the Medical Device/Pharmaceutical and Food industries and found the course to be extremely relevant to all industries.
If you’re spending money on an education program, make sure you choose one you’ll finish!
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