Biopharmaceutical & Medical Device Manufacturing
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 academic and industry professionals, you will gain 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.
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.
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.
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.
Post Course Info
With the continued growth of the Pharmaceutical and Medical Device industry in Ireland, this course is suitable for those who wish to upskill to gain either
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:
Product and Process Developer
Production Technician/ Operator
Quality Assurance Analyst