What you’ll learn – There are 2 modules in this 15-week program
Module 1 – Manufacturing Safe Medicines (Weeks 1-5)
In this module, you’ll learn about the systems used in pharmaceutical manufacturing. You’ll learn about the rules and regulations that need to be followed. 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.
Entry Requirements
You are a:
- Pipefitter
- Plumber
- Pipe Welder
- Electrician
- Instrument or Boiler Technician
- (i.e. those that can interpret technical drawings)
OR
You have Commissioning & Qualification experience in ANY industry such as:
- Oil and Gas
- Semiconductor
- Contract Engineering Consultancies
- Food Manufacturing
- Mechanical or Electrical Construction
- Plastics Manufacturing
- Service Industries to the Above
OR
You have worked in a GMP Regulated Pharmaceutical or Medical Device manufacturing environment
– NOTE: You are exempt from the first 5 weeks of the program and get a price reduction.
Typical roles
- Process Technician/Operator
- Manufacturing Technician/Operator
- Automation/Control Technician or Engineer
- Quality Assurance or Quality Control Specialist
- Maintenance Engineer or Technician
- Laboratory Technician, Biochemist, Microbiologist
- Project Manager
Already Have Validation Experience?
If you already have some experience working in Validation and know how to populate a 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
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.
A 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?
IQ, OQ PQ Templates
Check out this link on Validation Technicians
Check out Validation Salaries
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).
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.
Validation Technician
This role would be more focused on production and process, plant environment, smaller projects and equipment upgrades. You would need to generate a lot more reports and would be process focussed, have more job security and opportunities for career progression.
- Starting Salary: €30k to €36k
- After 2 Years: €36k to €45k
- After 5 Years: €45k to €50k
Validation Team Member
This role is more focused on working on capital projects, equipment focused, higher salary than Validation Technicians as there would be a lot of overtime associated with the role. You would also need to move to where the job located and you could be working away from home.
- Starting Salary: €35k to €45k
- After 2 Years: €40k to €55k
- After 5 Years: €50k to €65k
- Starting Salary: $40,800
- After 2 Years: $51,000
- After 5 Years: $61,200
Validation Team Member
- Starting Salary: $54,400
- After 2 Years: $68,000
- After 5 Years: $81,600
What Does the Online Classroom Look Like?
We use one centralized platform where you can log into your classroom. There you will get your weekly program materials and assignments, ask questions, reply to messages, and more.
GetReskilled Success Stories
Regina McNamara
“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
“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
“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.
Start Your Application
Click below to learn how to develop test protocols for an equipment system and to read and interpret P&IDs.
Talk To Our Team
USA/World
Call Geraldine: +1 (617) 901 9268
Ireland
Call Sinead: +353 (0)21 2409016
Delivered by an Industry Expert
Dr. Joe Brady
Full-time Validation Lead and Lecturer, Technological University Dublin
Dr. Joe Brady is full-time practicing Validation Lead and an assistant lecturer 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 programs ranging from MSc, MEngSc. BSc, to Certificate level, for a range of academic institution.
He is also a supervisor for MSc/MEngSc and PhD theses. Joe has over seventeen years project experience in the pharmaceutical, biopharmaceutical and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.
Your 10 or 15 Week Class Schedule
NOTE: If you worked in a GMP Regulated Pharmaceutical or Medical Device manufacturing environment, you are exempt from the first 5 weeks of the program and get a price reduction.
Module 1 – Manufacturing Safe Medicines (Weeks 1-5)
Module 2 – Commissioning and Qualification (IQ OQ PQ) of Equipment and Systems (Weeks 6-15)
Add On Program – 5-Week Advanced Career Coaching – Open Your Eyes to Modern Job Hunting
This is a practical course, not a theoretical one. There is no “filler” content. Each and every task is specially designed to take you one step closer to the job you want in a structured way.
The course is assessed using a mock application for a real job advert. You’ll complete a 9-step application process simulation for a BioPharma/MedTech job, using the relevant tools and techniques.
“I never realised how much I didn’t know”
That’s the most common feedback we get when people finish this programme. And it really doesn’t take that long to get that new knowledge and start putting it to good use…
Week 1 – Get a comprehensive understanding of BioPharma/MedTech Industry and figure out jobs you can do
Week 2 – Practice skills assessments, write, rewrite and customize CVs and resumes
Week 3 – Speculative job applications and how to research jobs available
Week 4 – Social Media, networking and interview preparation
Week 5 – End of Module assignment. Complete a 9-step application process simulation for a BioPharma/MedTech job, using the relevant tools and techniques.
On completion of this module you’ll be able to:
- Discuss your local BioPharma/MedTech manufacturing industry
- List the departments and job roles where your skills are best suited
- Understand your current skill set and how to discuss that with employers
- Network effectively both on and offline
- Write a CV and cover letter that are highly tailored to a job advert
- Write a speculative application and have a list of local companies appropriate for such an application
- Prepare for an interview
You’ll also have access to a program advisor who is there to offer support and guidance, offer personalized feedback and provide additional resources in any areas you need a little extra help.
At the end of the course, you’ll have confidence through a more strategic approach to job hunting. You’ll have a complete tool kit for modern job hunting.
Meet Claire
Claire runs GetReskilled’s Advanced Career Coaching Program – our specially devised job hunting program that will help you find a job.
Show Off Your New Skills: Get a Certificate of Completion
Once the program is over, complete a written assignment to get certified in Commissioning & Qualification (IQ OQ PQ) of Equipment and Systems
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