What does a qualification engineer do?
Qualification engineer responsibilities
Here are examples of responsibilities from real qualification engineer resumes:
- Manage commissioning and GMP qualification of a vial filling line and two secondary packaging lines.
- Manage Jenkins security by providing specific access to authorize developers/testers using project base matrix authorization strategy.
- Reassign to assist in HVAC duct qualification group.
- Develop the protocol for environmental monitoring of the GMP areas.
- Refactore and execute python scripts require for device stress testing.
- Check and design verify HVAC and pipe stress calculations and support location drawings.
- Participate in the reviewed and execution of the IQ/OQ/PQ of the new packaging line.
- Assist design engineers with the debugging part of the developmental stages of the projects.
- Maintain laboratory compliance to international and customer testing standards (ISO, AITM, ASTM).
- Lead and assist with factory and site acceptance (FAT/SAT) testing and IQ/OQ/PQ including documentation review and reporting.
- Participate in development team scrum planning meetings, create QA relate sprints in TFS, and log progress through completion.
- Assemble prototype circuits for experimentations and debugging.
- Provide independent quality assurance review and approval of validation documents for sites without appropriate QA resources.
- Authore and execute re-validation protocol for autumn and winter temperature/relative humidity mapping for warehouse to close a corporate CAPA.
- Project coordination and execution for a label change initiative support by a CAPA denoting particulate issues cause by existing label materials.
Qualification engineer skills and personality traits
We calculated that 12% of Qualification Engineers are proficient in Test Procedures, GMP, and Test Equipment. They’re also known for soft skills such as Speaking skills, Writing skills, and Creativity.
We break down the percentage of Qualification Engineers that have these skills listed on their resume here:
- Test Procedures, 12%
Created Validation Procedures, conducted final product qualification and validation testing, and generated acceptance and production test procedures.
- GMP, 8%
Managed commissioning and GMP qualification of a vial filling line and two secondary packaging lines.
- Test Equipment, 6%
Designed custom automated test equipment for validation and high performance data acquisition system for system load characterization.
- FDA, 6%
Authored and executed Control System Validation protocols and provided guidance on safety and regulatory needs per FDA GAMP requirements.
- IQ/OQ/PQ, 5%
Lead and assisted with factory and site acceptance (FAT/SAT) testing and IQ/OQ/PQ including documentation review and reporting.
- Python, 5%
Developed a parser in Python to process large test data sets from MongoDB for ease of analysis.
Common skills that a qualification engineer uses to do their job include "test procedures," "gmp," and "test equipment." You can find details on the most important qualification engineer responsibilities below.
Speaking skills. One of the key soft skills for a qualification engineer to have is speaking skills. You can see how this relates to what qualification engineers do because "industrial engineers sometimes have to explain their instructions to production staff or technicians before they can make written instructions available." Additionally, a qualification engineer resume shows how qualification engineers use speaking skills: "represented nusco in nrc audits and various utility/industry meetings (nugeq and epri). "
Writing skills. Many qualification engineer duties rely on writing skills. "industrial engineers must prepare documentation for other engineers or scientists, or for future reference," so a qualification engineer will need this skill often in their role. This resume example is just one of many ways qualification engineer responsibilities rely on writing skills: "created/conducted product transfer protocols; compiling data, writing reports, and submitting to the fda for product approval. "
Creativity. qualification engineers are also known for creativity, which are critical to their duties. You can see how this skill relates to qualification engineer responsibilities, because "industrial engineers use creativity and ingenuity to design new production processes in many kinds of settings in order to reduce the use of material resources, time, or labor while accomplishing the same goal." A qualification engineer resume example shows how creativity is used in the workplace: "maintained chemical inventory and submitted town sewer permit and epa stormwater permit. "
Listening skills. qualification engineer responsibilities often require "listening skills." The duties that rely on this skill are shown by the fact that "these engineers often operate in teams, but they also must solicit feedback from customers, vendors, and production staff." This resume example shows what qualification engineers do with listening skills on a typical day: "communicated and worked with pv group and developed suitable requirements as per urs specifications. "
Math skills. A commonly-found skill in qualification engineer job descriptions, "math skills" is essential to what qualification engineers do. Qualification engineer responsibilities rely on this skill because "industrial engineers use the principles of calculus, trigonometry, and other advanced topics in mathematics for analysis, design, and troubleshooting in their work." You can also see how qualification engineer duties rely on math skills in this resume example: "developed a visual c++ (mfc) based application to calculate real time statistics for gps sessions. "
Problem-solving skills. While "problem-solving skills" is last on this skills list, don't underestimate its importance to qualification engineer responsibilities. Much of what a qualification engineer does relies on this skill, seeing as "in designing facilities for manufacturing and processes for providing services, these engineers deal with several issues at once, from workers’ safety to quality assurance." Here is a resume example of how this skill is used in the everyday duties of qualification engineers: "resolved compliance issues, generating deviation reports in accordance with gmp regulations and fda standards. "
The three companies that hire the most qualification engineers are:
- Google4 qualification engineers jobs
- Mentor4 qualification engineers jobs
- Genesis AEC
3 qualification engineers jobs
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Compare different qualification engineers
Qualification engineer vs. Process engineer internship
A process engineering intern performs various tasks for an organization. These include collaborating with the technical team on cost savings, process efficiency improvements, and technology advancement, attending meetings with leadership teams, and participating in customer trials. Additionally, they may assist with the leadership or management teams in creating standard operating procedures. They are responsible for coordinating with engineers and work on projects assigned by the leadership. Ideal candidates for this role must have a degree in mechanical or industrial engineering, excellent communication skills, and knowledge and experience in process observation.
There are some key differences in the responsibilities of each position. For example, qualification engineer responsibilities require skills like "test procedures," "test equipment," "iq/oq/pq," and "hvac." Meanwhile a typical process engineer internship has skills in areas such as "process engineering," "process improvement," "data analysis," and "continuous improvement." This difference in skills reveals the differences in what each career does.
On average, process engineer interns reach similar levels of education than qualification engineers. Process engineer interns are 4.2% more likely to earn a Master's Degree and 0.5% more likely to graduate with a Doctoral Degree.Qualification engineer vs. Industrial engineering internship
An industrial engineer intern is a student working in a company to do industrial engineering tasks. Industrial engineering interns assist industrial engineers. They perform process improvement tasks such as the increase in production efficiency and lean manufacturing analysis. They design and implement improved facility layout to optimize product flow and provide improvement times. More so, they conduct self-study for the calculation of efficient performance time, create assembly line drawing, and determine ergonomic issues.
Each career also uses different skills, according to real qualification engineer resumes. While qualification engineer responsibilities can utilize skills like "test procedures," "gmp," "test equipment," and "fda," industrial engineering interns use skills like "continuous improvement," "lean manufacturing," "process improvement," and "data collection."
Average education levels between the two professions vary. Industrial engineering interns tend to reach higher levels of education than qualification engineers. In fact, they're 5.1% more likely to graduate with a Master's Degree and 0.5% more likely to earn a Doctoral Degree.Qualification engineer vs. Manufacturing engineering internship
A manufacturing engineering intern is responsible for assisting the manufacturing engineers on the plant's daily operations, analyzing the manufacturing process and procedures, and recommending strategic solutions to maximize productivity and minimize costs. Manufacturing engineering interns shadow the production staff, inspect the tools and equipment of the manufacturing, analyze the quality control documentation, and perform related administrative tasks to familiarize themselves with the plant structure. A manufacturing engineering intern must have excellent communication and organization skills, as well as the ability to adapt quickly to a fast-paced environment.
Some important key differences between the two careers include a few of the skills necessary to fulfill the responsibilities of each. Some examples from qualification engineer resumes include skills like "test procedures," "test equipment," "iq/oq/pq," and "python," whereas a manufacturing engineering internship is more likely to list skills in "continuous improvement," "lean manufacturing," "cad," and "solidworks. "
Manufacturing engineering interns earn the best pay in the technology industry, where they command an average salary of $49,245. Qualification engineers earn the highest pay from the technology industry, with an average salary of $101,204.Most manufacturing engineering interns achieve a similar degree level compared to qualification engineers. For example, they're 2.8% more likely to graduate with a Master's Degree, and 0.1% more likely to earn a Doctoral Degree.Qualification engineer vs. Senior process engineer
A Senior Process Engineer assesses a process efficiency, effectiveness, safety, and quality. They also conduct process improvement initiatives and custom product developments.
Types of qualification engineer
Updated January 8, 2025
