Minimum Entry Requirements;
You must be able to answer “YES” to ALL of the following 4 questions for this “Certificate in Validation”
- Do you have a sound understanding of GMP rules, regulations and guidelines?
- Can you read engineering documentation such as P&IDs and piping isometrics?
- Do you understand IQ, OQ and PQ?
- Can you populate an IQ OQ PQ Validation or Verification protocol used in the BioPharma/Medtech Industry?
NOTE:
If you answer “NO” to any of the 4 questions above, you will first need to take our ONLINE Starter Validation Course and learn commissioning & qualification of equipment and systems and how to populate an IQ OQ PQ Validation Protocol. This program covers all the entry requirements above.
What you’ll learn – There are three 10-week modules in this 30-week program
Module 1 – Pharmaceutical Facility Design (Weeks 1-10)
In this module, you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.
Module 2 – Planning a Validation Strategy (Weeks 11-20)
In this module, you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpins an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.
Module 3 – From URS to PQ – a Validation Project (Weeks 21-30)
This is a workshop driven module where you will develop a P&ID and then back-engineer it into a URS (User Requirement Specification) which will be used to identify the key process measurements that will form the basis of the Performance Qualification (PQ) test script
So What Is Validation?
Validation describes the process of creating an evidence trail to show that an action, process or system leads to a consistent and reproducible result. This ‘result’ is typically either taking a measurement or assessing product quality.
A Validation Engineer is responsible for planning, implementing and monitoring the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing.
They measure and analyze the process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced.
There is currently a high demand for trained validation engineers. As a result, salaries are highly competitive.
Need More Detailed Information?
What is a Validation Engineer?
What is a Validation Technician?
Check out Validation Salaries
Check out his tool on the “Validation Engineers | 5-Mistakes to Avoid on Your First Day”
What Kind of Roles Would I be Suitable For?
Depending on your current work experience, here are some of the typical roles you could retrain into and the expected salaries.
Some companies might call this role: CQV Engineer, C&Q Specialist, Validation Specialist
- Starting Salary: €35,000 to €45,000
- After 2 Years: €40,000 to €55,000
- After 5 Years: €50,000 to €75,000