ESTIMATED SALARY
$50k to $98k
Based on US job data
ESTIMATED SALARY
€35k to €85k
Based on Irish job data
DURATION
3 Module over 30 Weeks
Study Online 14 hrs/week
LEVEL
Intermediate – Advanced
Join 3024 Learners
APPLY BY
Wednesday 15th July
Class Starts: 23rd July
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
Minimum Entry Requirements;
You must be able to answer “YES” to ALL of the following for this Senior Validation Course
- 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.
Ideal for:
- Pipefitters / plumbers / pipe welders / electricians / instrument or boiler technicians (i.e. those that can interpret technical drawings)
Or - Those with Commissioning & Qualification experience in ANY industry
Or - Those with GMP manufacturing experience
…who want: a starter-level validation role in pharmaceutical manufacturing
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
- Starting Salary: €30,000 to €36,000
- After 2 Years: €36,000 to €45,000
- After 5 Years: €45,000 to €50,000
Some companies might call this role: CQV Engineer, C&Q Specialist, Validation Specialist
- Starting Salary: $54,400
- After 2 Years: $68,000
- After 5 Years: $81,600
- Starting Salary: $40,800
- After 2 Years: $51,000
- After 5 Years: $61,200
Your 30-Week Class Schedule
Your Class Director will check your study logs and only will release subsequent week’s materials to you if you have been logging in for more than 10 hours per week.
And he or she will proactively follow up with you to keep you on track.
Module 1 – Pharmaceutical Facility Design
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.
Week 1 – Controlling Air Quality and Clean Utilities Manufacturing Logistics Calculations
Week 2 – Purified Water Generation and Distribution
Week 3 – Clean Steam and Sterilization
Week 4 – Controlling Material and Personnel flows
Week 5 – Aseptic Processing and Vial Filling
Week 6 – Controlling Cleanrooms and Automation
Week 7 – Quality Systems for Cleanrooms
Week 8 – Construction Lifecycle for New and Modified Facilities
Week 9 & 10 – Complete an End of Module Assignment. Develop a site master plan for an aseptic manufacturing process and the design of its environmental control and clean utility systems.
You will complete the following activities and produce a number of deliverables during the program including:
- Calculating Mass Balances and Equipment Sizing
- Designing a Clean Utility generation and distribution system
- Defining the cleanroom layout for safe material and personnel flows
- Describing the Quality System necessary for manufacturing safe medicines
Module 2 – Planning a Validation Strategy
This module will give you a broad understanding of how to develop a Validation Master Plan (VMP) for a typical product lifecycle and to prepare the Process Validation Protocol for presentation during a regulatory audit.
Week 11 – What’s new in Validation and in Quality
Week 12 – ISPE Guidance Documents and ASTM E2500
Week 13 – Preparing for Process Validation
Week 14 – The Quality Plan, Change Control and the Validation Master Plan (VMP)
Week 15 – Process Validation
Week 16 – The Process Validation Report
Week 17 – Cleaning Validation
Week 18 – Health & Safety at the Operator/Product Interface
Week 19 & 20 – Complete an End of Module Assignment. Complete this module with 8 weeks of study and an extra 2 weeks to complete the end of module assignment.
Module 3 – From URS to PQ – a Validation Project
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.
Week 21 to 22 – Supplementary Content: Generation of Piping and Instrumentation Diagrams, URS for Hot Detergent and Hot PUW Generation and Distribution Skid System, Equipment List, Instrument List (Incl. both an Attachment and Video Link), Inline Components List (Incl. both an Attachment and Video Link), Piping Line List (Incl. both an Attachment and Video Link), P&ID Instrument Identification (Incl. Video Link Only)
Week 23 – P&IDs
Week 24 – URS Matrix
Week 25 – Workshop
Week 26 – Workshop
Week 27 – Workshop
Week 28 – Workshop
Week 29 – PQ Template
Week 30 – PQ Template
Academically Accredited by Technological University Dublin (TU Dublin)
This CPD Certificate (Continuous Professional Development) is academically accredited by Technological University Dublin (TU Dublin), Ireland subject to the submission of all assessments and end of module assignments.
- Level 7
- Program Credits (ECTS): 15
- Awarding Body: TU Dublin
Available Worldwide
This Pharmaceutical Validation Training Course (Certificate in eValidation) is available worldwide.
GetReskilled Success Stories
Regina McNamara
“I can Study Around Work and Family Commitments”
I’d recommend this course to anyone that wants to work in the Pharmaceutical and Medical Device Manufacturing industry and is interested in building a successful career in this area. The online experience is working well for me as I study around work and family commitments.
The companies I applied for were very impressed. I am currently working in Boston Scientific manufacturing Balloon Catheters for Gallstone patients.