Certificate in BioPharmaChem

Mechanical, Maintenance, Facility, Production, Manufacturing or Industrial Engineering Background?
Retrain ONLINE for Engineering Roles in the Pharma
Industry in 15-Weeks

Take our “Conversion Course into Engineering Roles in Pharma” to work in mechanical, plant, maintenance or facility engineering roles within the pharmaceutical & medical device industry.
  • Learn the air, water and steam systems that underpin aseptic/sterile processing
  • Learn how safe medicines are made using GMPs
  • Application Deadline: Wednesday 7th October

Image: Caspeo

Mechanical, Maintenance, Plant, Facility, Production, Manufacturing or Industrial Engineering Background? Retrain ONLINE for Engineering Roles in the Pharma Industry in 15-Weeks

Take our “Conversion Course into Engineering Roles in Pharma” to work in mechanical, plant, maintenance or facility engineering roles within the pharmaceutical & medical device industry.
The Fundamentals of Pharmaceutical Manufacturing Technologies Course GetReskilled

Image: Caspeo

Our learners work at industry-leading companies such as:

Pfizer Logo

Abbott Logo

Novartis Logo

GSK Logo

Lilly Logo

Novartis Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

J&J Logo

2 Modules over 15 Weeks
Study Online 14 hrs/week 

Starter – Intermediate
Join 3124 Learners

Wednesday 7th October
Class Starts: 15th Oct

Apply NOW & Retrain for Engineering Roles in the Pharma Industry
Apply NOW & Retrain for Engineering Roles in the Pharma Industry

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This Course is Right For You If;

  • You want to get from your current industry to working in a mechanical, plant, maintenance or facility engineering role in the Pharma and Med Device industry as fast as possible.
  • You already have an engineering degree and don’t want another university qualification at the same or lower level.

  • You want end-of-week progress checks and follow up by us to MAKE SURE you finish the course.

  • It’s delivered Part-Time online so you can learn from home (or anywhere). Study after the kids have gone to bed.

What Kind of Engineering Roles Could I Retrain For?

  • Mechanical Engineering
  • Plant Engineering
  • Maintenance Engineering
  • Facility Engineering
  • Quality/Environmental Engineering
  • Manufacturing/Production Engineering (Medical Device 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.

Minimum Entry Requirements

You must be one of the following;

  • Mechanical Engineer/Technician
  • 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 is a quality engineer and what do they do?

Join our students who work at industry-leading companies such as:

Pfizer Logo

Abbott Logo

Novartis Logo

Lilly Logo

Roche Logo

Amgen Logo

Sanofi Logo

GSK Logo

What you’ll learn:

There are 2 modules in this 15-week program

Module 1 – Manufacturing Safe Medicines (Weeks 1-5)

In this module, you’ll learn about the systems used in pharmaceutical manufacturing. You’ll learn about the rules and regulations such as Good Manufacturing Practices (GMPs) that you need to follow. And you’ll learn enough technical information to get you talking to employers.

Module 2 – Pharmaceutical Facility Design (Weeks 6 -15)

How do you make sure that the cleanrooms used in the manufacture of sterile medicines are absolutely safe? How do you make sure the water, steam and air used are pure? In this practical course, you will learn all this and more.

Hear From People Who’ve Taken This Course
Pharmaceutical Degree

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.”

Pharmaceutical Degree

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.”

Pharmaceutical Degree

Edel Harkins

“Highly recommended to anyone who has been out of the industry for a period of time”

“I would highly recommend anyone in my situation who has been out of the industry for a period of time to do these courses. They have contributed to my new found confidence in my existing and new qualifications, my improved interview skills and my new job!”

Computer System Validation

Noel O’Brien

“The quality of the course content was excellent and very substantial and covered all aspects associated within the Pharmaceutical, Bio-Pharmaceutical and Medical Device industries. Information that I feel could and would be very much a requirement for the type of work I would be seeking, within such companies.”

Computer System Validation

Ewa K.

“This course would give you chance to continue to seek an employment and at the same time you can study to improve your chances at the job market.”

Computer System Validation

James Fogarty

“This was fantastic opportunity for me to gain qualification in my own time. This would otherwise have been impossible due to cost and time due to child minding.”

Computer System Validation

Trish Kineen

“It has been a great course to re-familiarise myself with the area after such a long time away. I is also brilliant that you can study in your own time & at home (so you don’t have travel & child minding costs). I found the pace of the course good and really enjoyed it.”

Pharmaceutical Degree

Darren Deehan

“I have really enjoyed the course. The course content was very detailed and way surpassed my expectation. While the course was challenging, the online support and access was exceptional. I am really looking forward to progressing to the follow-on/specialization course, “BioValidation” when it becomes available.”

Pharmaceutical Degree

David Masterson

“The courses are detailed, easily accessible, great to add to your CV or to compliment other qualifications.”

Pharmaceutical Degree

Johan Rousseau

“Already told friends, and they are on the course. It is a good course to familiarize you with the Pharma Manufacturing Industry.”

Pharmaceutical Degree

Josephine Nelson

“I would recommend enrolling, the course is very interesting.”

Pharmaceutical Degree

Louise McManus

“Excellent course, well set out.”

Delivered by an Industry Expert

Dr.Joe Brady Lecturer at GetTeskilled

Dr. Joe Brady

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 courses 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.

What Does the Online Classroom Look Like?

How does Studying Online Work?

We use one centralized platform where you can log into your classroom. There you can get assignments, interact with faculty and peers, reply to message boards, and more.

Each week, you’ll complete a series of videos, quizzes, interactive activities and projects through our online platform, available to access 24/7.
We release only one week’s worth of material at a time and then MANUALLY check your activity logs weekly to make sure that you’re managing to keep up with your workload. This helps us to spot any potential issues early. And you’ll have a dedicated course leader who will follow up with you if it looks like you’re starting to fall behind.
Your working schedules are unpredictable so we offer flexible delivery. Slow down, speed up or pause the delivery of the course.

Your 15-Week Class Schedule

Your Class Director is going to check your study logs at the end of every week and will only release the following week’s materials to you if you have been regularly logging in and completed the previous week’s activities.

And he or she will proactively follow up with you to keep you on track.

Module 1 – Manufacturing Safe Medicines (Weeks 1-5)

  • Finished Medicinal Products
  • Focus on Patient Safety and Product Quality
  • ISO-9001 ‘Quality Management Systems — Requirements’
  • Product Quality and cGMP Practices
  • Process Validation
  • ASTM E2500 ‘Specification, Design & Verification of Manufacturing Systems’
  • PQ, OQ and IQ (Performance Qualification, Operational Qualification, Installation Qualification)
  • Cleaning Validation
  • Batch Organic Chemical Synthesis
  • User specification for a Reactor
  • Biopharmaceutical Manufacturing
  • Tablet Manufacturing
  • Aseptic & Sterile Manufacturing
  • Purified Water Generation, Storage & Distribution
  • Clean Steam
  • Water for Injection, Storage and Distribution
  • Engineering Aspects of Cleaning
  • Chemistry Aspects of Cleaning
  • Steam Sterilization
  • HVAC for Non-Sterile Manufacturing
  • Cleanroom Layout
  • Design Documents Required for the Generation of Installation and Functional Tests
  • User specification for a Reactor
  • Equipment Configuration and Process Sequence for a Reactor
  • Generation of Piping and Instrumentation Diagrams (P&ID)
  • URS for Hot Detergent and Hot PUW Generation and Distribution Skid System
  • Equipment List
  • Instrument List
  • Inline Components List

Module 2 – Pharmaceutical Facility Design (Weeks 6-15)

  • Manufacturing Logistics Calculations
  • Process Flow Diagram (PFD)
  • Controlling Air Quality
  • Heating, Ventilation, and Air Conditioning (HVAC) Systems
  • Biopharmaceutical Unit Operations – Drug Substance / Drug Product • Pharmacopeia Grade Waters
  • Process Support and Utilities
  • ISO 9001:2008
  • Typical GMP list for drug substance
  • Operational Activities
  • GMP for Personnel
  • Quality Systems Approach to Pharmaceutical cGMP Regulations – The Quality Systems Model
  • Maintenance: Good and Best Practices
  • Project Lifecycle for New and Modified Facilities
  • IPlant Layout
  • Layout For Bulk Process Building
  • Site Layout
  • IZoned Air Conditioning System
  • Isolator technology
  • IIsolators and RABs
  • Cell Breakage
  • IPurified Water
  • Purified Water Generation
  • IPurified Water Storage and Distribution
  • Clean Room and Clean Air Device Monitoring
  • Good Engineering Practices Procedures
  • GMPs for Buildings and Facilities
  • Maintenance Program
  • Conceptual Design – Part-I
  • HAVC Requirements for Non Sterile API Manufacturi
  • Plant Automation
  • Plant Steam
  • Clean Steam Generators
  • Clean Steam Generators 2
  • Steam Sterilization-In-Place
  • GMPs for Process Equipment
  • Quality Systems Approach to Pharmaceutical cGMP Regulations – Resources
  • Conceptual Design – Part-II
  • Air Flow Patterns
  • Air Flow Patterns Laminar Flow Systems
  • Cleanroom Layout General Introduction
  • Cleanroom Layout HVAC Containment (non-sterile API manufacturing)
  • Filter Ratings – European Standards
  • Filter Ratings – MERV Rating
  • Logic Gates Functions, and Programmable Logic Controller (PLC)
  • Water for Injection (WFI) Storage and Distribution
  • Principles of Good Engineering Practices (GEP)
  • Quality Systems Approach to Pharmaceutical cGMP Regulations – Manufacturing
  • Maintenance Work Execution
  • Site Master Planning – Part-I
  • Classification of Clean Areas – Vial Filling
  • Classification of Clean Areas – Cleanroom HVAC Configurations
  • Classification of Clean Areas – AHU
  • Classification of Clean Areas – Particles
  • Classification of Clean Areas – CFU
  • Area Classification Protection
  • Compressed Air, and Pneumatics
  • Aseptic Filling – Sterile Medicinal Containers
  • Aseptic Filling – Vial Inspection
  • Aseptic Filling – Vial Washing
  • Aseptic Filling – Vial Depyrogenation
  • Aseptic Filling – Vial Filling
  • Cleanroom Gowning
  • Aseptic Processing – Automated Loading System
  • Aseptic Processing – Manual Loading System
  • Aseptic Processing – Automated Barrier Systems
  • Cleanroom Monitoring – Physical Tests
  • Quality System – Evaluation Activities
  • Maintenance Management
  • Site Master Planning – Part-II
  • Open versus Closed Processing
  • Facility Layout Concept
  • Blow/fill/seal technology
  • PLC Programming
  • PLC Program Case Studies
  • Cleanroom Monitoring – Microbiological Tests
  • Cleanroom Monitoring – Cleanrooms Cleaning Procedures
  • Terminally sterilised products
  • EU Guidelines on Clean Room Aseptic preparation
  • HVAC Critical Parameters for Sterile and Non-Sterile Manufacturing
  • Batch Process Control
  • Nitrogen Supply and Distribution
  • Environmental Monitoring Program
  • ICH Q10 – Pharmaceutical Quality System
  • FDA Guidance on Aseptic Processing
  • Construction Lifecycle – New and Modified Facilities
  • Construction Lifecycle – Test Packs
  • Construction Lifecycle – Modular and Sustainability
  • Software Functional Block Diagram (FBD)
  • ASTM E 250
You will produce a number of deliverables during the course including:

  • Calculating Mass Balances and Equipment Sizing
  • Designing a Clean Utility generation and distribution system
  • Defining the cleanroom layout for safe material and personnel flows
  • Describing the Quality System necessary for manufacturing safe medicines
Develop a site master plan for an aseptic manufacturing process and the design of its environmental control and clean utility systems.
You will receive an end of course certificate from GetReskilled which along with others modules can build into an academic accreditation from the Dublin Institute of Technology (Ireland) subject to the following criteria;

  • Passing a written or oral Exam on the materials.
  • The submission of all assessments and the end of module assignment.

Options For Further Study

Take our 10-Week Starter Validation Training Program to learn to validate those purified air, water and steam systems and stand from the crowd

In this module, you will develop your own 100-page plus IQ OQ PQ Validation Protocol to commission and qualify a clean-in-place system along with:

  • How the intent of a process (like maintaining the product at the required temperature) is linked to the equipment that will be used to do this (heat exchanger, temperature transmitters, flow valve).
  • You’ll be able to develop your own functional test scripts based on the User Requirement Specifications to confirm that the installed equipment is fit-for-purpose, i.e. that it will do what it states that it will do.
  • Use a traceability matrix tool to ensure that all requirements defined within the User Requirement Specifications (URS) are tested in the test protocols
  • How to prioritise which parts of the equipment system are critical to validate and which parts are not etc, using component impact assessments and risk management tools.
  • How to read/interpret the engineering documentation ( P&IDs, Piping Isometrics & Electrical Loop Drawings) used to define the equipment system (drawings, specifications etc).
  • How to qualify equipment, instruments and piping systems, along with automation controls and building facilities.
  • How to document all of these steps in an IQ OQ PQ validation protocol which you will develop as your end of module assignment.
  • Be able to join a Validation Team Get the working knowledge of a Validation Team member, allowing you to take the first steps in your high-paying career.

And while we use a Clean-in-Place equipment system in the course notes and videos to explain all of these elements about validation, what you will learn on this course is transferrable to other process engineering systems.

Show Off Your New Skills: Get a Certificate of Completion

Once the course is over, complete a written assignment to get certified in The Fundamentals of Pharmaceutical Manufacturing Technologies

Add it to your resume or your LinkedIn profile.

Fundamentals of Pharmaceutical Manufacturing Technologies Course Certificate

GetReskilleld is an authorized LinkedIn education provider

You can add your education, certificates and everything you learned and earned at GetReskilled into the Education section of your profile.

GetReskilled LinkedIn

Frequently Asked Questions

Yes, this program is delivered fully online so you can learn from home (or anywhere). Study after the kids have gone to bed.

There are a total of 15 sessions of online content, one per week. Each session of online content typically includes 6-10 topics.

Each topic includes:

  • A set of course notes – these provide additional depth to the video content.
  • Warm-up self-assessment question – to recap or activate any relevant prior learning.
  • A video – these are typically 5-10 minutes long and deliver 80% of the course content.
  • Post video self-assessment questions to check how well you can recall this new material from memory.
  • Any follow up assessments or assignments.

We release only one week’s worth of material at a time and then c