Validation Engineers | 5-Mistakes to Avoid on Your First Day
By: Dr.Joe Brady and Donagh Fitzgerald B.Prod Eng. Last Updated: June 2023
The Problem
Over the years, we see validation and CQV engineer graduates make the same mistakes over and over again. Almost always, it’s simply due to a lack of experience. In response to that, we have tried to identify the 5 most common mistakes novices make and develop a decision-making scenario where they can practice making decisions in a fail-safe environment and learn to avoid these common mistakes.
Scenario Setup
Congratulations, it’s your very first day at work on a validation project!
You are a graduate validation engineer/technician on your very first day of work. You have to generate a validation protocol and deliver it on schedule on a new fast-track project. Take this decision-making simulation. Explore the various challenges you may encounter and see if you can avoid making 5 common mistakes on your first day.
Click on the bottom “Continue” tab to get started.
For Teachers
The online scenario is the homework part of a lesson plan and should be followed by a debrief session.
Download the Facilitator’s Guide here.
Learners need a debrief, some structured way to discuss how they are going to get through those first few days on the job, draw conclusions, build models and identify how they are going to change what they do. Feel free to add your thoughts to the comments section below.
Further Reading
You might also be interested in reading:
- What is pharmaceutical validation?
- What is IQ OQ PQ?
- What is an equipment validation protocol?
- What is process validation?
- What is a Validation Master Plan?
- The 8 most “in demand” skills for validation professionals
- Your pathway to a career in validation
About the Author
Dr. Joe Brady
Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled
Dr. Joe Brady is a full-time validation lead and also lectures with Technological University Dublin (TU Dublin), in the School of Chemical and Pharmaceutical Sciences. Joe is a certified trainer and highly experienced in competency-based training. He designs and prepares educational modules and full academic courses ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institutions.
He is also a supervisor for MSc/MEngSc and Ph.D. theses. Joe has over twenty years of project experience in the pharmaceutical, biopharmaceutical, and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.
Donagh Fitzgerald
Head of Marketing & Product Development
Mechanical/Production Engineer
Donagh looks after the marketing and product development including the training and pedagogical elements of our programs and makes sure that all GetReskilled’s users can have a great online learning experience. Donagh has lived and worked in many countries including Ireland, America, the UK, Singapore, Hong Kong and Japan. Donagh has also served as the Program Manager for the Farmleigh Fellowship based out of Singapore.
Donagh holds Degrees in Production Engineering and Mechanical Engineering from South East Technological University, Ireland.