This Course is Right For You If;
Minimum Entry Requirements
Ph.D., Masters, Degree, or Diploma in the following:
- Mechanical Engineer/Technician
- Maintenance Engineer/Technician
- Aircraft Maintenance Engineer/Technician
- Facilities Engineer/Technician
- Plant Engineer/Technician
- Production Engineer
- Manufacturing Engineer
- Industrial Engineer
- Civil Engineer
- Structural Engineer
- Graduate Engineer of any of the above
What Kind of Engineering Roles Could I Retrain Into?
Apart from the general “Maintenance Engineer” or “Plant Engineer” job titles, here are some typical job titles we often see advertised and that you could apply for (and depending on your previous experience);
- Maintenance Systems Lead – ownership of all preventative and corrective works on plant utilities and equipment.
- Maintenance Planner – the focus is on developing the company asset maintenance program and strategy.
- Lead Utilities Engineer – manage capital projects from inception to delivery and ensure plant availability is maximised.
- Clean Utilities Engineer – ownership of clean utilities systems including purified water, water for injection, clean steam, high quality compressed air, and nitrogen distribution.
- Facilities Engineer – ensure all preventative and corrective works on plant utilities and equipment are planned and executed.
- Mechanical Engineering
- Quality/Environmental Engineering
- Manufacturing/Production Engineering (Medical Device Manufacturing or Combination Product Manufacturing)
- Validation Engineering (with our add on validation program)
I already have an engineering degree. So why take this course?
Your skills are a great foundation for engineering roles in the pharmaceutical and medical device manufacturing industry and the engineering consultancies who work within this sector. But you need more..
You need to understand the industry regulations, the different regulatory standards (US, European, World Health Organization, etc), work practices, approaches to risk management, data integrity approaches, and industry protocols that are critical in the manufacture of safe medicines.
You also need to understand how the air, water and steam systems that underpin and support aseptic/sterile processing and cleanroom manufacturing work.
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Enroll in this course to learn…
- Introduction – to pharmaceutical, (bio)pharmaceutical manufacturing in a GMP (Good Manufacturing Practice) regulated environment, quality systems vs regulation vs validation
- Industry regulations and guidelines – including, FDA GMPs for the United States, EMA GMPs for Europen Union, ICH, and PICs GMP regulation
- FDA medical device rules – medical device regulations & guidelines
- GMPs vs ISO 9001:2015 – what’s the difference and why we use both
- Process validation and documentation – design and verification of manufacturing systems
- Supporting technologies – such as purified water generation, storage & distribution, clean steam, water for injection, storage and distribution
- Introduction to quality risk management (QRM) – and the importance of risk management and the basic steps involved in its application
- Key manufacturing technologies – such as organic chemical synthesis, biopharmaceutical manufacturing, tablet manufacturing and aseptic & sterile manufacturing
- Purified water generation – storage and distribution that underpin aseptic/sterile processing
- Clean steam – water for injection, storage and distribution that underpin aseptic/sterile processing.
- Instrumentation process control design – for the generation and distribution of clean utility systems.
- Cleanroom layout design – layout and classification along with the environmental controls pressure profiles
- Aseptic processing – lyophilization and how vials are filled in an aseptic environment
- Quality systems – for cleanrooms for both EMA and FDA guidance on aseptic processing.
- Professional writing skills program – This will guide you through the assignment writing process and equip you with the written communication skills you need for working in the industry
You’ll produce a number of deliverables throughout the program including…
- Complete 2 Quality Risk Management workshops on:
- Fault Tree Analysis (FTA)
- Failure Mode Effect Analysis (FMEA)
- Complete 14-question booklets (one for every week’s worth of content) which will summarise what you have learnt for the week and ensure you retain and understand the information.
- Complete an end of module assignment to include the following:
- Sketch and label process flow diagrams illustrating typical biopharmaceutical unit operations for the sequential manufacture of both drug substances and drug products.
- Describe process support and utility systems encountered on a typical biopharmaceutical facility
- Sketch and describe the configuration of a hypothetical cleanroom environment for aseptic processing (e.g. for vial filling operations).
- Describe the similarities and differences between pharmacopoeia grade purified water (PUW) and water for injection (WFI).
And take the following skills and knowledge back to work…
- You’ll have a strong foundation in how safe medicines and medical devices are made in a GMP regulated manufacturing environment.
- You’ll understand the air, clean water and steam systems that underpin aseptic/sterile processing.
- You’ll understand cleanroom layout design, layout and classification and the environmental controls pressure profiles
- You’ll have the technical knowledge and understanding of the quality culture necessary to work in this environment
Hear From People Who’ve Taken This Course
John Ryan
“The course content material is concise and interesting”
“The professionalism and passion of the lecturers comes across in the tutorials which gives the student confidence and encouragement to keep on top of the course. The course content material is concise and interesting. The timing of the release of the lessons is perfect, the student moves at a comfortable pace, one step at a time.”
Ronan Balfe
“I would have no hesitation in recommending these courses”
“Studying online gives you the time to do the course in your own time yet with assignment deadlines this made you disciplined to meet the deadlines set. I would have no hesitation in recommending these courses to anyone wishing to gain an education in the pharmaceutical sector.”