This Certificate is Accredited by a World Top 4% University
Technological University Dublin (TUD) is one of the largest universities in Ireland
Named Best Institute of Technology by the Sunday Times in 2010
Ranked in the top 100 by the Times Higher Education for universities under 50 in 2014 and 2015
- 28,500 registered students
Over 2,000 members of staff
This Course is Right For You If:
You want to turn your validation work experience into a University Certification and charge higher hourly rates.
You want more Senior Validation Engineer, Technician, CQV or C&Q roles and higher pay.
- Your work in Quality Assurance/Quality Control but have to sign off on validation documents you don’t fully understand!
You don’t want to waste your time or money on hotel or travel junkets.
Delivered part-time online so you can learn from home (or anywhere). Study after the kids have gone to bed.
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 Equipment Validation Training Course (ONLINE) – For Starter Validation Roles and learn commissioning & qualification of equipment and systems and how to populate an IQ OQ PQ Equipment 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
What Kind of Roles Would I be Suitable For?
The more validation work experience you have, the better positioned you’ll be to successfully apply for more senior roles upon completion of the program. Here are some of the most common job titles we see advertised and the expected salaries.
Validation Technician
Works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result.
Some companies might call this role:
- CQV Specialist
- C&Q Specialist
- Associate QA Validation Specialist
- C&Q Junior Project Manager
- Equipment & Process Validation Specialist
- QA Validation Associate
- QA Validation Specialist
- Validation & Technical Standards Specialist
- Validation Analyst – Qualification section
- Validation Specialist
- Starting Salary: €40,000 to €45,000
- After 2 Years: €45,000 to €60,000
- After 5 Years: €60,000 to €75,000
Validation Engineer
Rigorously test and pre-test the systems used to manufacture products and create and document an evidence trail to show that the systems and equipment used, produce a defect-free consistent result. This is a more senior role.
Some companies might call this role:
- CQV Engineer
- Manager / Associate Manager – QA Validation
- Mgr/ Snr Mgr QA Validation Oversight
- QA Validation Engineer
- Quality & Validation Engineer
- Senior Validation Engineer
- Senior Validation Specialist
- Staff Engineer, Quality/Validation
- Validation Scientist
- Starting Salary: €39,000 to €50,000
- After 2 Years: €45,000 to €60,000
- After 5 Years: €60,000 to €100,000
Validation Technician
Works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result.
Some companies might call this role:
- CQV Specialist
- C&Q Specialist
- Associate QA Validation Specialist
- C&Q Junior Project Manager
- Equipment & Process Validation Specialist
- QA Validation Associate
- QA Validation Specialist
- Validation & Technical Standards Specialist
- Validation Analyst – Qualification section
- Validation Specialist
- Starting Salary: $40,800
- After 2 Years: $51,000
- After 5 Years: $65,200
Validation Engineer
Rigorously test and pre-test the systems used to manufacture products and create and document an evidence trail to show that the systems and equipment used, produce a defect-free consistent result. This is a more senior role.
Some companies might call this role:
- CQV Engineer
- Manager / Associate Manager – QA Validation
- Mgr/ Snr Mgr QA Validation Oversight
- QA Validation Engineer
- Quality & Validation Engineer
- Senior Validation Engineer
- Senior Validation Specialist
- Staff Engineer, Quality/Validation
- Validation Scientist
- Starting Salary: $54,400
- After 2 Years: $68,000
- After 5 Years: $90,000+
Process Validation Engineer
This is generally considered an advanced role and requires thorough process knowledge and experience with process validation engineers working in engineering design, tech-transfer, upstream and downstream manufacturing. Most practitioners tend to have a lab/science, chemistry or chemical/process engineering background although or have learnt experientially on the job through extensive work experience.
Cleaning Validation Engineer
Design and develop cleaning procedures for new products and manufacturing equipment and also investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, deviations for non validated or underdeveloped cleaning procedures. This is a highly specialised role requiring in-depth knowledge of chemical cleaning processes so most practitioners tend to have a lab/science, chemistry or chemical/process engineering background or have learnt experientially on the job through extensive work experience or on-the-job training.
Some companies might call this role:
- Cleaning Validation Specialist
- QA Validation Specialist – Cleaning Validation
- QA Validation – Clean Hold Executor
Your 30-Week Class Schedule
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.
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.
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.