From Documentation to Execution: What Validation Engineers Deliver at cGMP Consulting
Validation engineers play a critical role in FDA-regulated environments, ensuring that manufacturing systems function as intended and meet all compliance requirements. Equipment qualification, facility qualification, and process validation are all necessary to achieve compliance requirements.
Strategic Planning and Cross-Functional Coordination
A core responsibility of the validation engineer is preparing validation and qualification documentation. This includes drafting protocols and distributing them in advance to approvers, project managers, and the departments involved in execution. Early coordination helps avoid delays and ensures all teams’ expectations are aligned.
In addition to documentation, the engineer manages the required materials and resources. This may include tubing, nozzles, gowning materials, and other essential supplies. If cleaning is needed before the run, the engineer ensures it is scheduled and completed. Personnel assignments and training are also arranged to confirm that qualified staff are ready and available.
Finally, updates are sent to the project team regarding time estimates of how long these runs should take and monitor how many commodities have been used. At completion, it’s important to compile all documentation from various departments that have played a role in the qualification and draft up and route the report and other validation documents required for the report such as materials used and coordination of post-calibration.
Execution Oversight and Documentation Compliance
During validation runs, the engineer is present to either execute or witness the activities. Their role is also to confirm that all paperwork complies with cGMP documentation principles. Even though systems may have passed Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), the qualification phase often presents issues due to site-specific or client-specific variables that are unavoidable.
Since these systems have already undergone FAT and SAT, one would expect qualification to go smoothly, given it’s a similar process to FAT and SAT, but it almost never does despite how much planning and testing was done beforehand.
Project Communication and Final Reporting
Throughout the execution phase, the engineer provides status updates to the project team, including timelines and material usage. These updates support decision-making and resource planning. After execution, the engineer compiles documentation from all contributing departments, drafts the final validation report, and ensures all supporting records—such as materials used and post-calibration data—are included.
Tools like Excel-based Gantt charts and Kanban boards are often used to organize tasks, track progress, and manage timelines.
Communication is a Key Skill
While technical knowledge is important, strong communication skills are often what set successful validation engineers apart. It is unexpected that each client, system, and site operates differently—even when equipment and processes are technically doing the “same thing”. Engineers must work closely with operators to understand process details and with quality and operations teams to ensure documentation expectations are met.
Being able to communicate clearly, manage cross-functional input, and maintain working relationships across teams is essential to the role. Everything is a high priority in validation work; it requires a quick turnaround and is subject to scrutiny. This dynamic environment is very motivating as it provides opportunities every day.
Conclusion
If you’re interested in learning more about our validation services or discussing how our team can support your next project, we invite you to connect. Visit our Contact Us page — we’re ready to help you meet your qualification and validation goals.
