What Kind of Jobs Can Quality Engineers Get in the Pharmaceutical and Medical Device Industry?
By: Donagh Fitzgerald B.Prod Eng and Gerry Creaner B.Chem Eng. Last Updated: October 2023
Now assuming that you are coming from a discrete manufacturing environment, the majority of quality assurance or quality control roles for those with production, manufacturing, industrial, or mechanical engineering backgrounds will be in medical device manufacturing as there is a much broader use of discrete manufacturing.
Pharmaceutical and biopharma may have a few roles but the majority (but not all) tend to be concentrated around packaging operations.
But as always, there will be exceptions.
If you came into quality from a mechanical engineering or plant engineering background, you could also look at environmental quality roles. Pharma needs purified water and clean air systems to manufacture safe medicines which are used for injections and part of your job would be to maintain and ensure the quality of the output of these systems.
Apart from “Quality Engineer” or “Senior Quality Engineer”, here are some of the more common job titles we see advertised.
- Senior R&D Quality Engineer
- Design Assurance Quality Engineer
- Quality Engineer – New Product Development
- Principal Supplier Quality Engineer
- Quality Engineer – Manufacturing Support
- Senior Manufacturing Quality Engineer
- Quality Engineer (QMS)
- Quality Assurance Engineer
- Quality Systems Engineer
NOTE: The majority of Quality Control roles in pharmaceutical manufacturing (and food processing) involve laboratory testing and for that reason, the majority of QC roles in the pharma sector tend to be filled by those with a lab/science background, not engineering/manufacturing backgrounds.
You would have roughly 2 broad options.
Option 1
Retrain for production quality roles within a GMP regulated medical device manufacturing environment.
Take our 18-week online Conversion Course into Engineering Roles in Pharma to learn GMPs and how safe medicines and medical devices are made in a regulated environment. You will also learn the air, water and steam systems that underpin medical device manufacturing.
Option 2
Retrain for environmental quality roles within a GMP regulated manufacturing environment.
Take our 18-week online Conversion Course into Engineering Roles in Pharma
As a quality engineer, you’d be well placed to work in environmental quality roles within both the pharmaceutical and medical device manufacturing space. Pharma needs purified water and clean air systems to manufacture safe medicines which are used for injections. These aseptic processes have to be designed, validated, monitored, maintained and updated in FDA regulated manufacturing facilities.
You will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpin an aseptic manufacturing facility and the quality systems.
Then take our 10-Week Online Starter Validation program to learn how those systems are validated.
About the Author
Donagh Fitzgerald
Head of Marketing & Product Development
Mechanical/Production Engineer
Donagh looks after the marketing and product development including the training and pedagogical elements of our programs and makes sure that all GetReskilled’s users can have a great online learning experience. Donagh has lived and worked in many countries including Ireland, America, the UK, Singapore, Hong Kong and Japan. Donagh has also served as the Program Manager for the Farmleigh Fellowship based out of Singapore.
Donagh holds Degrees in Production Engineering and Mechanical Engineering from South East Technological University, Ireland.
Gerry Creaner
President
Senior Lecturer with GetReskilled
Gerry Creaner has over 30-years of experience in the Life Sciences Manufacturing industry across a range of technical, managerial and business roles. He established a very successful engineering consultancy prior to founding GetReskilled, an online education and learning business, with offices in Singapore, Ireland and Boston (USA), focussed on the manufacture of safe and effective medicines for the public.
He is also a founding Director of two Singapore based philanthropic organizations, the Farmleigh Fellowship and the Singapore-Ireland Fund, both of which deepen the well established and historical Singapore – Ireland relationship and deliver long-term benefits to both countries.
Gerry has an undergraduate degree in Chemical Engineering (UCD, 1980) and an MSc (Management) from Trinity College Dublin (2003) and is currently doing research for his Ph.D.