I have worked as a QC Chemist with a major Biopharma company for the past 5 years. A big part of my role is Cleaning verification for Fill Finish Manufacturing. I do visuals and take swabs of various pieces of equipment and analyse by TOC, I also test rinses by TOC and Conductivity . I am interested in transitioning my career to that of Cleaning Validation Engineer and would appreciate some advice on how to go about doing this
You have to be able to identify the equipment, know where to get the drug product surface area and calculate the carryover acceptance criteria using a scientific basis.
I would say overall that verification discusses “what”. That is, what was done: did it follow the SOP, did we test all the sites that were required, what were the results. You are basically confirming that all tests met acceptance criteria. There isn’t much more behind the scenes so to speak.
While a validation engineer has to discuss “why”. That is why the specific sites were selected. Why other sites were excluded. Why the specific test method was selected (swab, rinsate, pH, TOC, HPLC, etc.). Validation Engineer basically designs the cleaning cycle, the sampling methods, selects the testing methods, trains personnel on how to clean, and how to sample, and how to test (etc.). To transition, your thought process has to start thinking big picture, risk mitigation (and yes risk acceptance to some degree using a risked based approach).
Also a validation engineer might be asked to discuss the strategy and risk and approach and results to a regulatory agency (so be prepared to sit in the hot seat).
All these activities take a specific approach, and require some reading, thinking, and training.
If you are interested, there are often courses and classed your can take through learnaboutGMP (shameless plug for this forum/website), and other websites (which I don’t want to list so as to compete with Graham O’Keefe’s awesome training courses).
Good luck. There are plenty of jobs here with lots of demand in cleaning validation. Doing just cleaning validation might be somewhat limiting from a career perspective. You might be interested in Validation in general, and do cleaning validation as one skill set. (just my two cents).
If you come from a QC background. Doing lab equipment qualificaion to supplement your cleaning validation experience might be a good combination and give you more opportunities.
You might speak to your manager. Alternatively, the company I work for is looking to recruit someone interested in moving up. If you’d like to reach out to me in linked in. My name is JaredCroft (just like my profile says). I’d like to talk about this direction a bit more.