Commissioning Qualification & Validation

Please Note
This programme is jointly offered by ATU Sligo and NIBRT (National Institute for Bioprocessing Research and Training).

An objective of this new postgraduate certificate programme in CQV is to help support new facilities and extensions with commissioning, qualification and validation work before manufacturing can commence. This programme presents a pathway for qualified graduates who wish to pursue a career in validation.

This postgraduate certificate is designed to provide students with the knowledge required to be involved in the commissioning of equipment and utilities used in biopharmaceutical plants. It will equip students with the knowledge and skills required to perform commissioning of a bioprocessing plant, and the equipment related to the biotechnology industry.

This course is particularly suited to individuals who are looking to enter the commissioning and validation space in the (bio)pharmaceutical manufacturing sector. Biopharmaceutical processing is a rapidly growing sector within the life-sciences industry, with immense opportunities for graduates. Global manufacturing of biopharmaceuticals has increased significantly over the last decade.

This programme will provide students with a comprehensive understanding of the challenges in the commissioning of biopharmaceutical manufacturing facilities. As a result, graduates can look forward to a wide range of career opportunities in a large and growing industry. Upon completion of the programme students will have achieved an internationally recognised qualification which is highly relevant to the biopharma and biotechnology industry.

Course Format

Semester 1
Title Credits
Facility Design and Operation 05
Biologics Manufacturing 05
Regulation, Risk and Compliance 05

Semester 2
Title Credits
Commissioning, Qualification & Validation 10
Scale-up and Technology Transfer 05

The programme is open to students who have obtained an honours degree (Level 8) or its equivalent in an appropriate discipline (i.e. Engineering or Life Sciences). Other candidates with alternative honours degrees and relevant experience in the BioProcessing industry (typically 5 years duration in a GMP environment) may apply for consideration through the IT Sligo RPL (Recognised Prior Learning) process.

Applications for online programmes are accepted on the atu sligo website.

All programmes advertised will run subject to sufficient student numbers.

ATU sligo online has two intakes per year, the main one being in September with a smaller listing of programmes for January. For confirmation on start dates check www.itsligo.ie/online

For September, applications open from 1st February each year. Closing date for receipt of applications is 31st august.

For January, applications open from 1st November each year. Closing date for applications is mid-January.

The online application form requires personal details, previous qualifications, professional accreditations, employment history and a personal statement. We recommend collating all the necessary paperwork i.e. Transcripts of previous qualifications, academic certificates before you submit an application.

Once submitted, our admissions team will contact you to confirm eligibility and request copies of any previous qualifications.

Academic staff review every application and approve eligible candidates for the programme.

Admissions team will notify you if you are accepted onto the course and will request deposit to confirm your place.

Places are limited, so please apply early.

1 year part-time

Delivery Method: Online

On-Campus Attendance
Two day attendance in NIBRT in semester 2

Most of our online courses have about 2-3 hours of live lectures per week (but this can vary per programme). The rest of your study time consists of independent learning, communicating with your lecturers and classmates and carrying out assignments.

Live lectures normally take place between 6pm and 10pm, Monday to Thursday but this may vary depending on the availability of specific lecturers. If the Live Classroom scheduled times for the live online lectures do not suit you, recordings will be made available through Moodle and other accessible platforms. These recordings can be downloaded and watched later, at a time that suits you.

Please note, you may be required to take some time off work for the below:

• Exams Christmas Exams: 2 – 4 days in January each year. Summer Exams: 2 – 4 days in May each year.

• Workshops/Practical Classes: Approximately 2 – 4 days per year depending on the course you are studying. You will receive notification of the dates from your lecturer for each specific subject requirement.

During our Online & Flexible Learning Induction, you will meet with your Course Co-ordinator who will be available to answer any questions you might have, and they will give you your timetable for the upcoming academic year.

If you have any further questions, please contact our Admissions Team on admissions@itsligo.ie.

To help balance work, life, and online learning, it is important to understand the time that you will have to dedicate to your studies. This will help you to stay focused, reduce stress, and achieve your goals while also working full-time.

For part-time online or blended learning, it is recommended that you should try to allow for 5-6 hours per week per 5 credit module to your studies.

Career Opportunities
This course is particularly suited to individuals who are looking to enter the commissioning and validation space in the (bio)pharmaceutical manufacturing sector. An objective of this postgraduate certificate programme in CQV is to help support new facilities and extensions with commissioning, qualification and validation work before manufacturing can commence. The focus will be on facilities and equipment.

Further Study
Upon successful completion of this programme students can progress onto the L9 BioPharmaceutical Science suite of programmes.It is also envisaged that this programme will provide an attractive progression pathway for Level 8 graduates who wish to undertake Level 9 studies with an interest in employment in the biologics industry.