The department that assesses and documents all equipment and processes to ensure that an action, process, or system leads to a consistent and reproducible result. (Check out this article for a much more detailed look at pharmaceutical validation, IQ OQ PQ and equipment validation protocols).
These jobs suit:
- Candidates with previous pharmaceutical manufacturing experience, looking to specialize
- People with previous work experience that requires them to read and interpret technical drawings (e.g. Pipe-fitters, Plumbers, Pipe Welders, Piping Supervisors, Boiler Technicians, and Electricians)
- Those with commissioning and qualification experience from any industry
Examples of jobs in this category include:
Validation Technician – works as part of the Validation team to measure and analyze the manufacturing process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result. This ensures that the product is consistently of the highest quality.
Some pharma companies might call this role:
- CQV Specialist
- C&Q Specialist
- Associate QA Validation Specialist
- C&Q Junior Project Manager
- Equipment & Process Validation Specialist
- QA Validation Associate
- QA Validation Specialist
Validation Team Member – This role is more focused on working on capital projects. It is typically equipment-focused and comes with a higher salary than Validation Technicians as there would be a lot of overtime associated with the role. You would also need to move to where the job is located and could be working away from home.
Also, some pharma companies might call this role:
- CQV Specialist
- Validation Specialist
- C&Q Specialist
With these validation roles, you could work directly for a pharmaceutical company on in-house projects or work for an engineering consultancy or engineering contractor as part of a project team on large capital projects.
Validation Engineer – responsible for planning, implementing and monitoring the validation strategy in highly regulated industries such as pharmaceutical or medical device manufacturing. They measure and analyze the process, audit and calibrate equipment and create a document trail that shows the process leads to a consistent result to ensure the highest quality products are produced.
Cleaning Validation Engineer – Design and develop cleaning procedures for new products and manufacturing equipment and also investigate and conduct troubleshooting/root cause analysis of cleaning related incidents, and deviations for non-validated or underdeveloped cleaning procedures. This is a highly specialised role requiring in-depth knowledge of chemical cleaning processes so most practitioners tend to have a lab/science, chemistry or chemical/process engineering background or have learnt experientially on the job through extensive work experience or on-the-job training.
Some companies might call this role:
- Cleaning Validation Specialist
- QA Validation Specialist – Cleaning Validation
- QA Validation – Clean Hold Executor
Process Validation Engineer – This is generally considered an advanced role and requires thorough process knowledge and experience with process validation engineers working in engineering design, tech transfer, upstream and downstream manufacturing. Most practitioners tend to have a lab/science, chemistry or chemical/process engineering background or have learnt experientially on the job through extensive work experience.
Computer System Validation (CSV) Specialist – plan, write, implement and review the Computer Systems Validation or CSV protocols in place within highly regulated manufacturing industries. Their work is essential to make sure that all computer-based systems are operating as intended (with documents to prove it) to meet regulatory requirements.
Click here for salary information for validation roles.
Click here for salary information for CSV roles.
How you’d change your career to a validation job in pharma: