By: Donagh Fitzgerald B.Prod Eng and Gerry Creaner B.Chem Eng. Last Updated: October 2023

As a process or chemical engineer, you are already well-positioned to apply for process or chemical engineering roles within the pharmaceutical manufacturing sector. You could also look at roles with medical device manufacturing companies as well. Engineering consultancies could also be another option.

You generally don’t need any additional training but you could certainly benefit from taking a course on GMPs if you have no experience working in a GMP manufacturing environment or have not covered them in your undergraduate program.

Another option would be to retrain for validation roles as your background in engineering design and interpreting P&ID technical drawings are highly relevant to this field.

Apart from the general “Process Engineer”, “Chemical Engineer” or “Senior Process Engineer” job titles, here are some typical sub-category job titles we often see advertised.

• Process Engineer – Tech Transfer – focus is generally on managing the move of a production process from one facility to another.
• Process Engineer – Upstream – Upstream activities are stages of biopharmaceutical processing up to the cell-culture or fermentation process that is used to make the target proteins.
• Process Engineer – Downstream – Downstream activities are the stages of processing that come after cell culture or fermentation. These stages include separation and purification to achieve the required drug product.
• Process Engineer – Fill Finish – focus is on formulating the licensed product using the drug substance and other excipients, filling, lyophilization and testing, including ongoing stability testing.

Other subcategories – a lot of the job descriptions for these job titles tend to overlap with other engineering disciplines such as mechanical, plant or validation engineering.

• Process Engineer – EHS – focus on environmental, health and safety
• Process Engineer – Facilities – focus is on the design and maintenance of HVAC, air handling, water and steam systems within a plant
• Process Engineer – C&Q – focus is on commissioning and qualification of equipment and systems and populate validation protocols
• Process Engineer – Equipment – focus is on the maintenance, qualifications and documentation to keep process equipment up and running and in regulatory alignment.

You would have roughly 3 broad options to bolster your qualifications.

Apply for process or chemical engineer roles with pharmaceutical manufacturers or engineering consultancies.

Polish up your CV/Resume and apply as you are. You could apply for advertised positions or you could send out speculative job applications.

For a list of pharmaceutical and medical device manufacturers and engineering consultancies, click here if you are in Ireland and here if you are in the United Kingdom. Read this article to see the Top 10 Pharmaceutical & Medical Device Industry Hubs in the USA. For other locations, do a search for engineering consultancies for the pharma of med device sector.

You might consider bolstering your qualifications by taking our 6-week GMPs Training Course for Beginners in the Pharmaceutical Industry to learn about the Good Manufacturing Practices (GMPs) and the risk management techniques used in the FDA regulated manufacturing environment.

Retrain for validation roles in both pharmaceutical companies and engineering consultancies. 

Take our 15-week Online Starter Validation program and learn to populate an IQ OQ PQ Validation Protocols.

Validation Protocols form a crucial part of pharmaceutical plant projects and having a fundamental understanding of how these protocols are put together and interpreted is a fundamental skillset of any process or chemical engineer working in this area.

Options for further study.

Take our 30-week online Certificate in Validation program for More Senior Validation, CQV and C&Q Roles to get a level 7 university qualification from Technological University Dublin, Ireland and a more interesting job with a higher salary such as;

• Validation Engineer
• CQV Engineer
• C&Q Engineer
• Manager / Associate Manager – QA Validation
• Mgr/ Snr Mgr QA Validation Oversight
• QA Validation Engineer
• Quality & Validation Engineer
• Quality Assurance Engineer (Validation)
• Quality Validation Engineer
• Senior Validation Engineer
• Staff Engineer, Quality/Validation
• Validation Scientist

Take our Computer System Validation Course and extend your role to CSV Projects. Round out your qualifications and give yourself a competitive edge in the marketplace.

Retrain to get a better understanding of the plant engineering and validation process used in pharmaceutical companies.

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.

Here, you’d need to take the following programs

Take our 18-week online Conversion Course into Engineering Roles in Pharma to learn GMPs and how safe medicines are made in a regulated environment and learn the air, water and steam systems that underpin aseptic/sterile processing.

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.