Become a validation engineer requires analytical, scientific and product design skills to ensure equipment and processes operate as planned. Hiring managers often want to learn how your experience and expertise can help them write testing protocols and validate product performance and functionality. Learning about some of the common validation engineer interview questions can help showcase your abilities to impress hiring managers. In this article, we discuss some of the general, experience-based and in-depth questions you might expect in an interview and provide some sample answers you can use when preparing.
- What is process validation? …
- Which is the latest guidance document for process validation published by USFDA? …
- According to regulatory guidelines (USFDA), what are the stages of process validation? …
- How many batches to be considered for process validation?
Process validation: Interview Questions and Answers, QA/QC
Can you describe your testing process?
This is an in-depth question where interviewers hope to learn about your process. Consider including details about each step in your process and how they build toward a successful validation. If possible, share a specific experience where you followed these steps and had a successful result.
Example: “First, I read the customer requirements to understand what the expected functions are. Once I understand them thoroughly, I establish what type of testing is required, such as functional or performance testing or a combination of multiple. Ill then write test cases, perform the testing and record the results. I will then communicate with the team the results of the test, recommendations and will repeat them until the equipment passes.
I followed these steps when testing a new construction arm at my last position and found a measurement inconsistency during calibration that we fixed to ensure the equipment passed during the next test.”
What’s one thing you think you could improve on?
Interviewers might ask this question to learn about your self-awareness. Identifying areas where you might improve and sharing how you plan to improve them shows that you have a growth mindset and can motivate yourself toward continual development. Try maintaining a positive attitude with this question and focusing on how youve improved and will continue to improve.
Example: “Sometimes, while testing, I redo the same test step multiple times just to be sure that Im testing properly, which can cause delays. Im committed to delivering results, so I strive to be as accurate as possible. To improve this, I spend more time designing the test cases to ensure that when I test, the results will be accurate the first time, as they usually are.”
Are searching for a job to work as a process engineer or validation engineer? If yes, then we are here to help you through your job search. Browse through a list of latest job opportunities related to the process validation job given on the wisdomjobs page and get hired in one of the top rated industries. Process validation is the central part in most of the production and manufacturing industries such as pharmaceutical goods and medical device industry. In a Process Validation job you will get a chance to analyze the data related to the designing of a product in order to establish that the process is capable and reliable of producing quality standard products. Our team has gathered some Process Validation job interview questions and answers which will help you to face the job interview confidently and get a permanent job.
FAQ
What are types of validation in pharma?
- A) Prospective validation (or premarket validation)
- B) Retrospective validation.
- C) Concurrent validation.
- D) Revalidation.
What are the three types of validation?
Why do you need 3 batches for validation?
