• Turn your validation work experience into a university accredited certificate

• Get a more interesting job with a higher salary. Charge higher hourly rates.

• Estimated salaries €45,000 – €100,000 plus overtime, bonuses and allowances. (Based on Irish job data)

• NFQ: Level 7

• Application Deadline: Wednesday 19th July

University Accredited by TU Dublin Ireland

Our learners work for the world’s biggest pharma and medical device companies

Minimum Entry Requirements:

You must be able to answer “YES” to ALL of the following 4 questions for this “Certificate in Validation”

1. Do you have a sound understanding of GMP rules, regulations and guidelines?
2. Can you read engineering documentation such as P&IDs and piping isometrics?
3. Do you understand IQ, OQ and PQ?
4. Can you populate an IQ OQ PQ Equipment Qualification 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 Qualification 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

View Full 30 Week Syllabus

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

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

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

This CPD Certificate (Continuous Professional Development) is university-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

This Pharmaceutical Validation Training Course (Certificate in eValidation) is available worldwide.

Hear from people who taken this program

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.

Having faced a career change in the middle of an economic downturn, I lost some of myself confidence and needed a major boost. The area of Biopharmaceutical operations and validation was of interest to me as it does play an important role in the pharmaceutical industry at present.

I have now been working at Johnson and Johnson Vision Care as a Validation Engineer and I look forward to putting what I have learned into practice.

I found the course 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.

Full-Time Validation Lead
Lecturer, Technological University Dublin, Ireland
Senior Associate, GetReskilled

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 twenty years of project experience in the pharmaceutical, biopharmaceutical, and medical device industries in Ireland, Singapore, China, The Netherlands, France and the USA.

Senior Lecturer, Technological University Dublin

Professor Anne Greene is a Senior Lecturer in Pharmaceutical Technology, Validation and Pharmaceutical Quality Assurance to undergraduate and postgraduate students and a Pharmaceutical Projects Manager at Technological University Dublin, Ireland.

In addition, Anne is the Director of the Pharmaceutical Regulatory Science Team and is also secretary of the Parenteral Drug Association (PDA) Secretary, Irish Chapter. Her experience ranges from a technical service chemist, Sterling Wintrop Dungarvan, (now GSK), validation manager at startup Wyeth Newbridge, (now Pfizer) and is a Training Director at NIBIRT in Ireland.

If you’re spending money on an education program, make sure you choose one you’ll finish!