Process Engineer

Summary of the role

A Process Engineer is an expert in designing, implementing, and optimising the systems and processes used to manufacture a product. They ensure that manufacturing processes are efficient, scalable, safe, and cost-effective. They are often the link between the scientists who develop a process at a small scale and the manufacturing teams who execute it at a larger, commercial scale. In the life sciences, this is especially important due to the need for strict regulatory compliance and product quality.

Typical Duties

The duties of a Process Engineer are a mix of strategic planning and hands-on problem-solving:

• Process Design and Development: You will design new manufacturing processes or refine existing ones. This involves creating process flow diagrams, selecting appropriate equipment, and ensuring the process is robust enough to produce a consistent, high-quality product.
• Scale-Up and Technology Transfer: A key responsibility is to take a process from a small-scale lab environment and “scale it up” for large-scale production. This involves running pilot batches, testing the process on a larger scale, and transferring the technology and knowledge to the manufacturing team.
• Troubleshooting and Optimisation: When a manufacturing process isn’t running as it should, you will be a key investigator. You’ll analyse data, identify the root cause of the problem, and develop engineering solutions to fix it. You’ll also continuously look for ways to improve efficiency, reduce costs, and enhance safety.
• Validation and Documentation: You’ll be responsible for creating and executing validation protocols (e.g., Installation Qualification, Operational Qualification, Performance Qualification) to prove that equipment and processes work as intended. You’ll also write and update Standard Operating Procedures (SOPs) and other critical documentation for regulatory purposes.
• Cross-functional Collaboration: You’ll work closely with a wide range of teams, including R&D, Manufacturing, Quality Assurance, and Facilities/Maintenance. Your role is to be the technical expert who ensures all parties are aligned on the manufacturing process.

While the core principles are the same for advanced therapies and broader life sciences, the specific focus changes:

Advanced Therapies: The work would be centred on processes for cell and gene therapies. This requires a deep understanding of bioprocessing equipment like single-use bioreactors, chromatography systems, and ultrafiltration. You’d be focused on maintaining the integrity of highly sensitive, often personalised, biological materials.

Wider Life Sciences: You might be working with a broader range of products, from large-scale protein production to vaccine manufacturing. The engineering challenges might be more focused on managing large-scale industrial equipment, automation, and optimising process yields.

Key Skills and Qualifications (UK)

Essential Qualifications: A Bachelor’s or Master’s degree in a relevant engineering discipline is almost always required. Common degrees include Chemical Engineering, Mechanical Engineering, or Biochemical Engineering.

Essential Certifications: A solid understanding of Good Manufacturing Practice (GMP) is crucial. While not always a formal certification, demonstrating this knowledge is essential for working in a regulated environment. Achieving Chartered Engineer (CEng) status with a professional body like the IChemE is highly desirable and can significantly boost career progression and salary.

Essential Skills:

• Analytical and Problem-Solving: The ability to use data and engineering principles to diagnose and solve complex problems.
• Technical Expertise: A strong, hands-on understanding of manufacturing equipment and processes.
• Attention to Detail: Meticulousness is vital for creating accurate documentation and ensuring compliance.
• Communication: Excellent verbal and written communication skills are necessary for collaborating with diverse teams and writing detailed reports.

Salary Expectations (UK)

Starting Salary: For an entry-level Process Engineer in the UK, a starting salary is typically in the range of £30,000 – £40,000 per year.

After 3-4 Years: With a few years of experience and a strong track record of successful projects, a Process Engineer can expect to earn between £45,000 – £60,000. Progression to senior roles and the achievement of chartered status will lead to even higher salaries.