What does a senior validation engineer do?
In the manufacturing industry, a Senior Validation Engineer specializes in inspecting and developing tools, equipment, and procedures, ensuring they adhere to company standards. Their responsibilities typically involve understanding project requirements, performing installations and calibrations, troubleshooting problems, creating and implementing tests, and conducting extensive research and analyses. They must also maintain records of all transactions and procedures, organize and update databases, and prepare reports regularly. Moreover, as a Senior Validation Engineer, it is essential to lead and serve as a mentor to junior validation engineers, all while implementing the company's safety standards and regulations.
Senior validation engineer responsibilities
Here are examples of responsibilities from real senior validation engineer resumes:
- Manage changes, deviations, investigations, and CAPAs via TrackWise.
- Maintain and manage positive working relationships while assisting in all stages of CAPA management and resolution.
- Manage all site validation activities including equipment qualification, management of outside validation consultants, change control and QA calibration approval.
- Major focus are to review, participate in process validation, FMEA, remediation, IQ/OQ/PQ.
- Develop validation protocols (IQ/OQ/PQ), write test scripts and lead process validation activities for various manufacturing processes.
- Assess change controls, facility work orders and equipment risk assessments to ensure compliant/validate state of all GMP equipment and systems.
- Interact with FDA investigators regarding cleaning validation compliance issues and regulatory requirements.
- Design global guidelines for CSV SDLC phases and validation activities.
- Prepare OQ and PQ scripts as per functional requirements and the GXP standards in QC.
- Perform deviation investigations and help to implement CAPA and re-validation as necessary.
- Perform QA validation of computer and automate systems associate with manufacturing processes.
- Streamline procedures for equipment/utility qualification and CSV using risk assessment and standardization.
- Develop qualification protocols for laboratory instruments utilize for QC analytical and microbiological testing purposes.
- Generate validation protocols, execute and provide final reports to comply with the FDA legislation requirements.
- Well verse in GMP procedures and validation requirements and experience at gathering technical information from vendors and scientific literature.
Senior validation engineer skills and personality traits
We calculated that 8% of Senior Validation Engineers are proficient in FDA, GMP, and Project Management. They’re also known for soft skills such as Leadership skills, Time-management skills, and Problem-solving skills.
We break down the percentage of Senior Validation Engineers that have these skills listed on their resume here:
- FDA, 8%
Completed approximately 25 additional Process Validations, several of which were successfully reviewed by the FDA during facility inspections.
- GMP, 7%
Support annual review activities for GMP Autoclaves including data analysis and final summary report generation.
- Project Management, 4%
Project Management, task coordination and executive management with documentation of progress for several projects at a time.
- Computer System, 4%
Provided engineering support to validate equipment, processes, test method, and computer systems associated with remediation and validation activities.
- Cleaning Validation, 4%
Perform gap analysis of existing cleaning validation program and responsible for implementing new program at start-up monoclonal antibody manufacturing facility.
- Summary Reports, 4%
Generated Validation documents such as the Qualification Plan, development and execution IOQ/PQ protocols, Deviations, Non-Conformances and Summary reports.
Most senior validation engineers use their skills in "fda," "gmp," and "project management" to do their jobs. You can find more detail on essential senior validation engineer responsibilities here:
Leadership skills. The most essential soft skill for a senior validation engineer to carry out their responsibilities is leadership skills. This skill is important for the role because "to keep the production process running smoothly, industrial production managers must motivate and direct employees." Additionally, a senior validation engineer resume shows how their duties depend on leadership skills: "provided leadership to cross-functional teams to perform technology transfers, process validation, and optimization activities. "
Problem-solving skills. senior validation engineers are also known for problem-solving skills, which are critical to their duties. You can see how this skill relates to senior validation engineer responsibilities, because "production managers must identify and address problems that arise." A senior validation engineer resume example shows how problem-solving skills is used in the workplace: "participated in defects resolution process by coordinating with developer, application manager and sme. "
The three companies that hire the most senior validation engineers are:
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Compare different senior validation engineers
Senior validation engineer vs. Engineer
Engineers are highly trained professionals who determine the feasibility of various projects, usually related to the construction industry. They are considered experts in mathematics and science, two disciplines that they need to use in designing and coming up with plans for projects. They should also be well-versed in different construction or industrial materials, and they ensure that appropriate materials are used for the project. They also ensure that the projects meet the requirements of the groups that hired them. They create spaces that would both address the needs of the end-users and the industry standards. They also ensure that the projects they make would stand the test of time.
While similarities exist, there are also some differences between senior validation engineers and engineer. For instance, senior validation engineer responsibilities require skills such as "fda," "gmp," "computer system," and "cleaning validation." Whereas a engineer is skilled in "python," "cloud," "c++," and "c #." This is part of what separates the two careers.
Engineers tend to make the most money working in the automotive industry, where they earn an average salary of $97,672. In contrast, senior validation engineers make the biggest average salary, $99,979, in the pharmaceutical industry.On average, engineers reach similar levels of education than senior validation engineers. Engineers are 4.9% less likely to earn a Master's Degree and 0.6% less likely to graduate with a Doctoral Degree.Senior validation engineer vs. Validation specialist
A validation specialist participates in validation, calibration, and temperature mapping activities. You will perform various tasks that include measuring software or instrument performance, establishing and maintaining methods for controlling the manufacturing process, and developing efficient ways to analyze data and monitor product performance. As a validation specialist, you are responsible for developing and testing algorithms and performing failure analysis and software and hardware debugging. You are also expected to work closely with senior engineers to improve the quality assurance and development process.
Each career also uses different skills, according to real senior validation engineer resumes. While senior validation engineer responsibilities can utilize skills like "project management," "process validation," "sme," and "gamp," validation specialists use skills like "laboratory equipment," "acceptance criteria," "validation process," and "validation studies."
Validation specialists may earn a lower salary than senior validation engineers, but validation specialists earn the most pay in the manufacturing industry with an average salary of $92,762. On the other hand, senior validation engineers receive higher pay in the pharmaceutical industry, where they earn an average salary of $99,979.validation specialists earn lower levels of education than senior validation engineers in general. They're 6.6% less likely to graduate with a Master's Degree and 0.6% less likely to earn a Doctoral Degree.Senior validation engineer vs. Equipment validation specialist
Validation Analysts are responsible for the accurate review and assessments of systems and processes within an organization. For example, a model valuation analyst has the task of assessing quantitative rules and statistical models that will help banks manage credit risks and other financial risks. Their duties include evaluation of risk models, developing validation plans, conduct statistical testing, and inspecting data. They also liaise with internal stakeholders to resolve model issues, maintain findings documentation as well as prepare report for senior management.
There are many key differences between these two careers, including some of the skills required to perform responsibilities within each role. For example, a senior validation engineer is likely to be skilled in "fda," "project management," "computer system," and "cleaning validation," while a typical equipment validation specialist is skilled in "oq," "maximo," "equipment repair," and "osha."
Equipment validation specialists typically earn similar educational levels compared to senior validation engineers. Specifically, they're 2.2% less likely to graduate with a Master's Degree, and 1.9% less likely to earn a Doctoral Degree.Senior validation engineer vs. Validation analyst
Types of senior validation engineer
Updated January 8, 2025
