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 serioulsy boost your application for 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 2nd December

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 seriously boost your application for 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 for the world’s biggest pharma and medical device companies

Pfizer Logo

Abbott Logo

Novartis Logo

GSK Logo

Lilly Logo

Novartis Logo

MSD Logo

Boston Scientific Logo

Medtronic Logo

Takeda Logo

Abbvie Logo

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DURATION
2 Modules over 15 Weeks
Study Online 14 hrs/week 

LEVEL
Intermediate
Join 3124 Learners

APPLY BY
Wednesday 2nd December
Class Starts: 10th Dec

Apply NOW & Retrain for Engineering Roles in the Pharma Industry

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

Apply NOW & Retrain for Engineering Roles in the Pharma Industry

Try Us Risk FREE for 7 Days 100% Money Back Guarantee.

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?

Our learners work for the world’s biggest pharma and medical device companies

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)

  • Topic-1 Finished Medicinal Products
    In this lesson, we learn about medical products and the various ways drug products are administered.
  • Topic-2 Focus on Patient Safety and Product Quality
    In this lesson, we will develop a deeper understanding of the importance of patient safety and product quality for medicines and medical devices.
  • Topic-3 ISO9001:2008
    This lesson is about the key requirements of a quality management system.
  • Topic -4 Product Quality and Current Good Manufacturing Practices [ cGMP ]
    In this lesson, we learn how to scientifically define product quality. This lesson also gives an insight into the high-level principles of current good manufacturing practices (cGMP).
  • Topic -5 API Regulatory Guidelines
    In this lesson, we describe the characteristics of a GMP that can be followed to manufacture an API.
  • Topic-6 ISO-9001 ‘Continual Improvement’ & ICH Q10 Pharmaceutical Quality System
    This lesson explains the concept of ‘continual improvement’ as part of a company’s quality management system and describes an effective corrective action process and a preventive action process (CAPA). It also gives details on the product-lifecycle for a pharmaceutical product and describes the monitoring of process performance and product quality.
  • Topic-7 Quality Systems Approach to Pharmaceutical cGMP Regulations-The Quality Systems Mode
    In this lesson, we describe a quality system model in accordance with management responsibilities, resources, manufacturing operations, and evaluation activities.
  • Topic-8 FDAMedicalDeviceRules-CFR820
    In this lesson, we look at how the FDA classifies medical devices and explore the basis of that classification system.
  • Topic -9 Medical Device Regulations and Guidelines – ISO 13485 / CFR 820
    In this lesson, we look at some GMP regulatory and ISO guidance documents that are associated with the manufacture of medical devices.
  • Topic-1 Process Validation
    In this lesson, we will learn about the various definitions of ‘validation’, as well as for ‘commissioning’, ‘qualification’ and ‘verification.
  • Topic-2 ASTME2500 – Standard Guide for Specification, Design and Verification
    In this lesson, we will describe a specification, design, and verification approach for equipment systems associated with the pharmaceutical, biopharmaceutical and medical device industries.
  • Topic-3 PQ,OQ and IQ
    In this lesson, we are going to define the terms installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and we will also list what typical project design documents are required to prepare such testing protocols.
  • Topic-4 Cleaning Validation
    This class takes a high-level look at a typical cleaning validation sequence. It looks at how to determine the basis for quantification limits and explains how to determine cleanliness levels on the basis of the analytical testing of representative samples. Sampling is described in terms of sampling-equipment, sampling -locations, and sampling –procedures.
  • Topic-5 Introduction to Quality Risk Management (QRM)
    In this lesson, we will develop an understanding of the history and the crucial importance of risk management as well as the basic steps involved in its application.
  • Topic -6 Fault Tree Analysis (FTA) – step 4 ‘Workshop’ exercise
    In this lesson, we learn about the risk management tool ‘Fault Tree Analysis’ and see an example of where and how we can use it.
  • Topic -7 Failure Mode, Effects (and Criticality) Analysis (FMEA / FMEAC) – Step 4 ‘Workshop’ exercise
    This presentation shows an example of the main steps in performing a ‘Failure Mode, Effects Analysis’ (FMEA) and describes how this risk management technique summarizes the important modes of (a) failure, (b) factors causing these failures, and (c) the likely effects of these failures.
  • Topic-8 Documenting the Quality Risk Management Process
    In this lesson, we take a practical look at managing a complete risk management process in terms of identifying risk, analyzing risk, evaluating risk, and controlling risk.
  • Topic-1 Batch Organic Chemical Synthesis
    In this lesson, we describe the typical equipment and process stages of the manufacture of active pharmaceutical ingredients (API) using batch organic chemistry synthesis
  • Topic-2 Biopharmaceuticals Manufacturing, Upstream, Fermentation
    This lesson describes a conventional biotechnological process and introduces the following process sequences:

    • Stage-I – Upstream Processing
    • Stage-II – Fermentation / Bio-reaction
    • Stage-III – Downstream Processing
  • Topic -3 Tablet Manufacturing
    In this lesson, we will explore the critical process parameters and quality attributes associated with the manufacture of medicinal tablets.
  • Topic -4 Aseptic & Sterile Manufacturing
    In this lesson, we look at critical process parameters and quality attributes associated with aseptic processing and terminal sterilization products for parenteral products.
  • Topic-1 Purified Water (PUW) Generation, Storage and Distribution
    In these presentations we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • Topic -2 Clean Steam Generators
    The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation
  • Topic -3 WFI Storage and Distribution
    In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain its specification
  • Topic -4 Engineering Aspects of Cleaning, and Cleaning Equipment
    This class discusses how to clean and decontaminate surfaces using CIP (clean-in-place), agitated Immersion, static Immersion (Soaking), and automated parts washers, ultrasonic cleaning, high-pressure spraying, and manual cleaning
  • Topic-5 Chemistry Aspects of Cleaning
    This lesson explores chemistry aspects of cleaning in terms of solubility, solubilisation, emulsification, dispersion, wetting, hydrolysis, oxidation and physical removal.
  • Topic -6 Steam Sterilization in Place
    In this lesson, we look at the mechanism behind sterilization of process equipment using saturated steam.
  • Topic-7 HVAC Requirements for Non-Sterile API Manufacturing
    In this lesson, we look at how to use airflow direction as a means of a containment barrier between
    operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
  • Topic-8 Cleanroom Layout–2 videos
    In these presentations, we take a high-level look at a common cleanroom configuration and discuss items
    such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals.
  • Topic -9 Area Classification Protection
    In this lesson, we observe a range of airlock configurations typically used in combination with safety under operational conditions to maintain the specification of critical environmental zones, such as those used in open processing, that have a major impact on product quality and patient.
  • Topic -10 Cleanroom Gowning
    In this lesson, we describe clothing that will minimize dispersion from skin and clothing for personnel working within a cleanroom environment
  • Topic -11 Cleanroom Monitoring – Physical Tests
    In this lesson, we discuss typical physical tests to monitor cleanroom environments: non-viable particle counts, pressure differentials, airflow velocity, air change rate, and filter integrity testing.

Write a 4-5 page essay, which you could present at a job interview to clearly demonstrate your Technical Knowledge and Understanding of the Quality Culture necessary to work in a GMP regulated manufacturing environment. It will confirm your understanding of how to Manufacture Safe Medicines and Medical Devices in a GMP regulated environment and will include the following topics:

  • The key requirements of a quality management system
  • The manufacturing responsibilities for quality systems
  • The cleaning validation sequence and how to determine cleanliness levels
  • The documentation of a complete risk management process in terms of identify risk, analyzing risk, evaluating risk and controlling risk.
  • The typical equipment and process stages used in the manufacture of active pharmaceutical ingredients
  • The critical process parameters and quality attributes associated with the manufacture of tablets.
  • The generation, storage and distribution of pharmacopeia grade Purified Water (PUW).
  • The common cleanroom configuration and airflow direction that governs personnel and material flows in a biopharmaceutical manufacturing environment

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

  • .1 Manufacturing Logistics Calculations
    In this lesson, we learn how to determine the size and capacity of primary processing equipment based on patient dosage requirements and the number of potential patients.
  • 1.2 Process Flow Diagram (PFD)
  • 1.3 Controlling Air Quality
    In this lesson, we take our first look at an air handling unit (AHU) and describe its functions.
  • 1.4 Heating, Ventilation, and Air Conditioning (HVAC) Systems
    In this lesson, we take a look at an overall heating and ventilation control (HVAC) system and explain its primary attributes.
  • 1.5 Basic Biopharmaceutical Unit Operations
    • 1-5-1 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug substance manufacturing operation.
    • 1-5-2 In this presentation we look at the basic biopharmaceutical unit operations that make up a typical drug product formulation/fill-finish and packaging/labeling manufacturing operation
  • 1.6 Pharmacopeia Grade Waters
  • 1.7 Process Support and Utilities
    In this lesson, we take a look at the clean utilities requirements for a biopharmaceutical drug substance manufacturing process.
  • 1.8 Introduction to ISO 9001:2008
    This lesson is about the key requirements of a quality management system.
  • 1.9 Typical GMP list for drug substance
    This presentation explores the content of ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”.
  • 1.10 Operational Activities
    In this lesson, we take a look at how to maintain a critical computerized system in a state of operational control using standard procedures.
  • 1.11 GMP for Personnel
  • 1.12 Quality Systems Approach to Pharmaceutical cGMP Regulations – The Quality Systems Mode
    In this lesson, we describe a quality system model in accordance with management responsibilities, resources, manufacturing operations and evaluation activities.
  • 1.13 Maintenance: Good and Best Practices
    In this lesson, we describe basic and good practices associated with maintenance in a regulated environment.
  • 2.1 Project Lifecycle for New and Modified Facilities
    In this lesson, we describe the typical phases of a project lifecycle: conceptual design, tender contract analysis, basic engineering, detailed design, and project realization.
  • 2.2 Plant Layout 
    In these presentations, we explore the vertical distribution of process equipment for a bulk process building, the horizontal layout for a bulk process building, and an entire site layout for an integrated biopharmaceutical manufacturing site.
  • 2.3 Zoned Air-Conditioning Systems
    In this presentation, we look at a practical example where a HVAC system can be dynamically operated to control the temperature of a room (space
  • 2.4 Isolator Technology 
    In this lesson, we explain the principals behind the use of ‘isolators’ and Restricted Access Barrier Systems (RABs) for critical ‘open processing’ operation
  • 2.5 Cell Breakage
    In this lesson, we describe a mechanism for bacterial cell disruption for the recovery of intracellular products.
  • 2.6 Purified Water (PUW) Generation, Storage and Distribution 
    In these presentations, we look at methodologies to generate, store and distribute pharmacopeia grade purified water (PUW).
  • 2.7 Clean Room and Clean Air Device monitoring 
  • 2.8 Good Engineering Practices Procedures
    In this presentation, we will develop an understanding of good engineering practices, and learn about some various organizations that produce them.
  • 2.9 GMPs for Buildings and Facilities 
  • 2.10 Quality Systems Approach to cGMP Regulations – Management Responsibilities
    In this lesson, we outline management’s role in the design, implementation, and management of the quality system.
  • 2.11 Maintenance Program
    In this lesson, we describe the key aspects of a typical maintenance program.
  • 3.1 Conceptual Design – Part-1
    In this lesson, we begin to explore a quantified effort in how to size, shape, program and cost an investment.
  • 3.2 HVAC Requirements for Non-Sterile API Manufacturing
    In this lesson, we look at how to use airflow direction as a means of a containment barrier between operational areas in a non-sterile multi-product active pharmaceutical ingredient (API) manufacturing facility.
  • 3.3 Plant Automation
    This lesson is an introduction to conventional process control using one-way digital and analog signals
  • 3.4 Plant Steam
    In this lesson, we describe a process for generating and distributing plant steam to various processes within a manufacturing facility, and also describe how to manage any resultant condensate.
  • 3.5 Clean Steam Generators 
    The objective of this lesson is to demonstrate how we produce clean steam using ‘Single-Effect Distillation’ ‘Multiple-Effect Distillation
  • 3.6 Steam Sterilization in Place
    In these presentations, we look at the mechanism behind the sterilization of process equipment using saturated steam.
  • 3.7 GMPs for Process Equipment 
  • 3.8 Quality Systems – Resources
    In this lesson, we describe what resources need to be allocated for a quality system and operational activities.
  • 4.1 Conceptual Design – Part-2
    This lesson describes what influences the layout of a facility in terms of Layers, Preliminary Layout, Process Layouts, Media and Buffer Preparation, Clean Utilities and CIP, Access Corridors, Warehouse / Material Movements, Personnel Movements, Decisions on Height, Air Handling, General Utilities, Electrical, Controls & Automation, Finishes, Structural / Civil, Cost Estimate, and Schedule.
  • 4.2 Air Flow Patterns 
    In these presentations, we look at laminar air-flow patterns in the context of filling open vessels aseptically, and at the configuration and operation of both a laminar flow booth and a laminar flow cabinet typically found in the biopharmaceutical industry.
  • 4.3 Cleanroom Layout 
    In this lesson, we take a high-level look at a common cleanroom configuration and discuss items such as airflow direction, filter arrangements, cleanroom garments, and personnel and material flows. Another objective of this lesson is to also gain an understanding of personnel and material flows in a controlled airflow environment designed to contain high potency chemicals.
  • 4.4 Filter Ratings 
    In these presentations, we look at the particle retention efficiencies of air filters of various grades rated in accordance with European normalisation standards EN779 and EN1822. We also look at the particle arrestance efficiency of air filters of various grades rated in accordance with the ASHRAE standard 52-2 ‘Minimum Efficiency Reporting Value (MERV Rating)’.
  • 4.5 Logic Gates Functions and PLC 
  • 4.6 WFI Storage and Distribution
    In this lesson, we take a look at a process for the storage and distribution of pharmacopeia grade water for injection (WFI) and how to maintain it