Biopharmaceutical & Medical Devices Manufacturing

Course Overview

This Higher Diploma is specifically designed to enable those, with a qualification in science or engineering, to successfully transition into technical or professional roles within the Biopharmaceutical and Medical Device sectors and to upskill those working in the sector to fill existing and emerging skills needs of the industry.



This programme combines a blend of Pharmaceutical and Medical Device Manufacturing modules with a range of business and industry-directed modules. Designed and delivered by highly experienced academics and industry professionals, you will gain the advanced skills and knowledge that companies are looking for. Our professional development team will help you all the way. We'll help you to tailor your CV towards an area that you are interested in getting a job in and use our industry contacts to help you get your foot in the door.



Accreditation: QQI Level 8 Higher Diploma in Biopharmaceutical and Medical Device Manufacturing.

Collaborating University: Technical University Dublin – Tallaght Campus

Course Modules Include:

Module 1: Aseptic Processing and Utilities

Provides the student with the skills and knowledge required for an Aseptic Manufacturing Environment.



Module 2: Regulatory Affairs and GMP

In-depth study of the Regulatory and GMP requirements of the pharmaceutical and medical device industries.



Module 3: Medical Device Operations

Medical Device, Design and Development, Regulations, Technologies, Packaging and Sterilization.



Module 4: Biopharmaceutical Processes

Equipment and processes of biopharmaceutical manufacture, including upstream/downstream processing.



Module 5: Pharmaceutical Process Chemistry

In-depth study of API production, focusing on scale-up, process optimization and unit operation.



Module 6: PAT and Process Validation Statistics

Requirements for validation of GMP equipment and facilities with hands-on experience of SPC and PAT.



Module 7: QRM Principles in Pharma and Medical Device

Evaluate and implement QRM strategies, ensuring compliance within these regulations.



Module 8: Lean Operations and Deviation Investigation Methods

Includes Lean and Six Sigma, CAPA, effective report writing and preparation for regulatory inspections.



Module 9: Finished Dose Formulation and Manufacturing

In-depth understanding and hands-on experience of drug formulation, manufacturing and packaging.



Module 10: Communication Skills and Work Preparation

Communication, leadership and career development skills for success in the life science sector.

This course is suitable for those with higher-level qualifications at NFQ Level 7 (180 ECTS Credits, typically 3 years of study) in science, engineering or relevant discipline.

Apply Online using the Application Weblink / Enquire Online above and member of our admission team will be in contact through phone or email.

12 months. Lectures are delivered 2 evenings per week Online and 2 Saturdays per month on campus. Labs are held in one of our pilot facilities with times and dates subject to scheduling. (ECTS: 60 Credits)

Next Intake: Summer 2025

Career Options

A technical position within the Pharma/Medical Device Industries in roles such as QC, QA, Project Management, Engineering, Managerial, etc.

or

Supplement their existing core skills to pursue a similar role within the Pharma/Medical Device Industries in areas such as Finance, HR, IT etc.



Potential Roles Include:



Project Engineer

Product and Process Developer

Production Technician/ Operator

Maintenance Support

Quality Assurance Analyst

Process Technicians

Support Services

Medical vigilance / surveillance and risk management

Process business improvement specialists / managers

Quality assurance specialist / manager